Is there a generic for Ibuprofen?

Yes. The FDA Orange Book lists 186 approved generic (ANDA) applications for Ibuprofen, referencing the brand CALDOLOR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ibuprofen?

CALDOLOR (NDA 022348, APOTEX) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ibuprofen?

The Orange Book lists 10 patents against Ibuprofen products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Ibuprofen have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Ibuprofen. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Ibuprofen are approved?

Ibuprofen is approved in the following dosage forms: capsule, solution, suspension, suspension/drops, tablet, tablet, chewable.

FDA Orange Book · active-ingredient family

Ibuprofen

Ibuprofen: 22 brands, 186 generics; first approved Mar 05, 1984; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 186 ANDA applications approved.

Earliest patent expiry Sep 30, 2029Latest exclusivity ends May 11, 2026

Brands (NDA)

Generics (ANDA)

186

Listed patents

Next patent expiry

Sep 30, 2029

in 3 yr

Brand (NDA) products

Originator applications

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CALDOLORRLDRS

APOTEXNDA 02234820093 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG/4ML (100MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	-
800MG/8ML (100MG/ML)	SOLUTION	INTRAVENOUS	Rx	-
800MG/200ML (4MG/ML)	SOLUTION	INTRAVENOUS	Rx	-

MIDOL LIQUID GELSRLDRS
BIONPHARMANDA 0214722002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG CAPSULE ORAL OTC -
INFANT'S ADVILRLDRS
HALEON US HOLDINGSNDA 02081220002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/2.5ML SUSPENSION/DROPS ORAL Discontinued -
50MG/1.25ML SUSPENSION/DROPS ORAL OTC -
CHILDREN'S MOTRINRLD
KENVUE BRANDSNDA 02060119962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, CHEWABLE ORAL Discontinued -
100MG TABLET, CHEWABLE ORAL Discontinued -
CHILDREN'S MOTRINRLDRS
KENVUE BRANDSNDA 0206031996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL OTC -
CHILDREN'S MOTRINRLDRS
KENVUE BRANDSNDA 02051619952 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
200MG/10ML SUSPENSION ORAL OTC -
ADVIL LIQUI-GELSRLDRS
HALEON US HOLDINGSNDA 02040219952 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
MOTRIN IBRLD
KENVUE BRANDSNDA 01901219904 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
200MG TABLET ORAL Discontinued -
200MG TABLET ORAL OTC -
200MG TABLET ORAL Discontinued -
MOTRINRLD
MCNEIL CONSUMERNDA 0198421989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -
ADVILRLDRS
HALEON US HOLDINGSNDA 0189891984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
MOTRINRLD
MCNEIL CONSUMERNDA 017463-4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
300MG TABLET ORAL Discontinued -
600MG TABLET ORAL Discontinued -
800MG TABLET ORAL Discontinued -
CHILDREN'S ELIXSURE
MOBERG PHARMA NORTHNDA 0216042004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -
CHILDREN'S ADVIL
HALEON US HOLDINGSNDA 02094419982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, CHEWABLE ORAL OTC -
100MG TABLET, CHEWABLE ORAL OTC -
JUNIOR STRENGTH ADVIL
HALEON US HOLDINGSNDA 0202671996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL OTC -
CHILDREN'S ADVIL
HALEON US HOLDINGSNDA 02058919962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
100MG/5ML SUSPENSION ORAL OTC -
JUNIOR STRENGTH MOTRIN
KENVUE BRANDSNDA 0206021996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL OTC -
MOTRIN
MCNEILNDA 0204761995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL Discontinued -
MOTRIN
MCNEIL PEDNDA 02013519942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, CHEWABLE ORAL Discontinued -
100MG TABLET, CHEWABLE ORAL Discontinued -
MOTRIN
MCNEIL PEDNDA 0204181994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
IBU
ABBOTTNDA 0197841989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -
CHILDREN'S ADVIL
HALEON US HOLDINGSNDA 0198331989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -
IBU
BASFNDA 018197-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
600MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/2.5ML	SUSPENSION/DROPS	ORAL	Discontinued	-
50MG/1.25ML	SUSPENSION/DROPS	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET, CHEWABLE	ORAL	Discontinued	-
100MG	TABLET, CHEWABLE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/ML	SUSPENSION/DROPS	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-
200MG/10ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-
200MG	TABLET	ORAL	Discontinued	-
200MG	TABLET	ORAL	OTC	-
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Discontinued	-
300MG	TABLET	ORAL	Discontinued	-
600MG	TABLET	ORAL	Discontinued	-
800MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET, CHEWABLE	ORAL	OTC	-
100MG	TABLET, CHEWABLE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/ML	SUSPENSION/DROPS	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET, CHEWABLE	ORAL	Discontinued	-
100MG	TABLET, CHEWABLE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Discontinued	-
600MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (186)

Abbreviated applications

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IBUPROFEN
RUBICON RESEARCHANDA 2202392026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
PAI HOLDINGS PHARMANDA 2147892024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
SHANDONG XINHUAANDA 20241320244 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
300MG TABLET ORAL Rx -
IBUPROFEN
AUROBINDO PHARMA LTDANDA 2135062024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL OTC -
IBUPROFEN
PATHEON SOFTGELSANDA 2172362024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
AUROBINDO PHARMA LTDANDA 2157772023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
SUN PHARMA CANADAANDA 2172612023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL OTC -
IBUPROFEN
STRIDES PHARMAANDA 2140712022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/1.25ML SUSPENSION/DROPS ORAL Discontinued -
IBUPROFEN
STRIDES PHARMAANDA 2153112022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Rx AB
IBUPROFEN
YICHANG HUMANWELLANDA 21531820223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
ALKEM LABS LTDANDA 21469920213 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
STRIDES PHARMAANDA 2116662021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
YICHANG HUMANWELLANDA 2140032020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
AUROBINDO PHARMA LTDANDA 21379420203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
ULTRATAB LABS INCANDA 2090762020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
ANNORA PHARMAANDA 2106022018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
GUARDIAN DRUGANDA 2107552018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL OTC -
IBUPROFEN
SUNSHINEANDA 20406220183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
600MG TABLET ORAL Discontinued -
800MG TABLET ORAL Discontinued -
IBUPROFEN
GUARDIAN DRUGANDA 2101492018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
AUROBINDO PHARMA LTDANDA 2077532018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
STRIDES PHARMAANDA 2069892018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
AUROBINDO PHARMA LTDANDA 2091792018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
ONESOURCEANDA 2044692018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
AUROBINDO PHARMA LTDANDA 2091782018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Rx AB
IBUPROFEN
ASCENT PHARMS INCANDA 2069992017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
AUROBINDO PHARMAANDA 2088652017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
SUN PHARMA CANADAANDA 2092072017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
SUN PHARMA CANADAANDA 2092042017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Rx AB
IBUPROFEN
STRIDES PHARMAANDA 2070522017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SHANDONG XINHUAANDA 20709520172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
200MG TABLET ORAL OTC -
IBUPROFEN
PAI HOLDINGS PHARMANDA 2056472016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -
IBUPROFEN
GRANULESANDA 2023122016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
SOFGEN PHARMSANDA 2035992016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
HUMANWELL PURACAPANDA 2065682016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
GRANULESANDA 09162520153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
AMNEAL PHARMSANDA 0792332014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
AMNEAL PHARMSANDA 2023002011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
ARISEANDA 2004572011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -
IBUPROFEN
STRIDES PHARMAANDA 0913552011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
STRIDES PHARMAANDA 0791292011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
MARKSANS PHARMAANDA 0912372011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
MARKSANS PHARMAANDA 0912392011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
MARKSANS PHARMAANDA 09079620103 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
GRANULES INDIAANDA 0791742010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
TRIS PHARMA INCANDA 0790582009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL OTC -
IBUPROFEN
P AND L DEV LLCANDA 0773382009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
MARKSANS PHARMAANDA 0792052009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
BIONPHARMAANDA 0786822009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE ORAL OTC -
IBUPROFEN
STRIDES PHARMAANDA 07832920093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
NORTHSTAR HLTHCAREANDA 07813220073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
600MG TABLET ORAL Discontinued -
800MG TABLET ORAL Discontinued -
IBUPROFEN
AMNEAL PHARMS NYANDA 07855820073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
L PERRIGO COANDA 07711420053 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
600MG TABLET ORAL Discontinued -
800MG TABLET ORAL Discontinued -
IBUPROFENRS
PERRIGO R AND DANDA 0773492005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
PADAGIS USANDA 0769252004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Rx AB
IBUPROFEN
LNKANDA 0767412004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
IBUPROFEN
PERRIGOANDA 07635920042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, CHEWABLE ORAL Discontinued -
100MG TABLET, CHEWABLE ORAL OTC -
IBUPROFEN
AVEMA PHARMAANDA 0764602003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
PERRIGOANDA 0759952002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
DR REDDYSANDA 0756612001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
DR REDDYS LABS INCANDA 0761172001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
DR REDDYSANDA 07568220013 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
DR REDDYS LABS INCANDA 07611220013 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
600MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
P AND LANDA 0749161999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
JUNIOR STRENGTH IBUPROFEN
L PERRIGO COANDA 0753671999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
IBUPROFEN
LNKANDA 0750101999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
LNKANDA 0751391999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
CHILDREN'S IBUPROFEN
PERRIGOANDA 0749371998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL OTC -
IBUPROFEN
L PERRIGO COANDA 0752171998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/ML SUSPENSION/DROPS ORAL OTC -
IBUPROFEN
CONTRACT PHARMACALANDA 0749311998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
CONTRACT PHARMACALANDA 0747821998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG CAPSULE ORAL Discontinued -
IBUPROFENRS
ACTAVIS MID ATLANTICANDA 0749781998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Rx AB
IBUPROFEN
SANDOZANDA 0745251995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SANDOZANDA 0745331995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
MCNEILANDA 0730191994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
CONTRACT PHARMACALANDA 0736911994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
TEVAANDA 0733431992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
TEVAANDA 0733441992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
TEVAANDA 0733451992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
TEVAANDA 0731411992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
ANI PHARMSANDA 0729011991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
ANI PHARMSANDA 0729031991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0722491989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBU-TAB
ALRAANDA 0710581988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBU-TAB
ALRAANDA 0710591988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBU-TAB
ALRAANDA 0719651988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBU-TAB 200
ALRAANDA 0710571988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
ADAPTISANDA 0722991988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
AMNEAL PHARMS NYANDA 0721991988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
ALLIEDANDA 0718701988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
IVAX SUB TEVA PHARMSANDA 0720401988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0719051988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SANDOZANDA 0718071988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
NUPRIN
BRISTOL MYERSANDA 0720351988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
NUPRIN
BRISTOL MYERSANDA 0720361988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
HALSEYANDA 0721371988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0716391988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0716441988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
PUREPAC PHARMANDA 0719641988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
RISINGANDA 0719381988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
SANDOZANDA 0720641988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
SANDOZANDA 0720651988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
SANDOZANDA 0721691987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
CAP-PROFEN
PERRIGOANDA 0720971987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
PERRIGOANDA 0720961987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL OTC -
IBUPROFEN
PERRIGOANDA 0720981987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
TAB-PROFEN
PERRIGOANDA 0720951987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SENORES PHARMSANDA 0719991987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0720041987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
IVAX SUB TEVA PHARMSANDA 0711541987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
AMNEAL PHARMS NYANDA 0719351987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Rx AB
IBUPROFEN
WATSON LABSANDA 0719111987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
MERRO PHARMANDA 0709851987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
HALSEYANDA 0710271987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
CONTRACT PHARMACALANDA 0717351987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0717651987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
MIDOL
BAYERANDA 0706261987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG CAPSULE ORAL Discontinued -
MIDOL
BAYERANDA 0710021987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG CAPSULE ORAL Discontinued -
MIDOL
BAYERANDA 0705911987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
MIDOL
BAYERANDA 0710011987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPRIN
PLIVAANDA 0717731987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0715471987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
PLIVAANDA 0716661987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
PLIVAANDA 0716671987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
PLIVAANDA 0716681987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
ACHES-N-PAIN
LEDERLEANDA 0710651987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
IVAX SUB TEVA PHARMSANDA 0717691987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
STRIDES PHARMA INTLANDA 0715751987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0712291987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
HALSEYANDA 0710281987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MG TABLET ORAL Discontinued -
IBUPROFEN
HALSEYANDA 0710291987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
HALSEYANDA 0710301987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
SUN PHARM INDUSTRIESANDA 0714481987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
AMNEAL PHARMS NYANDA 0713331987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
PUREPAC PHARMANDA 0716641987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
ANI PHARMSANDA 0711441987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0713381986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MG TABLET ORAL Discontinued -
IBUPROHM
OHM LABSANDA 0712141986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
AMNEAL PHARMS NYANDA 0713341986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Rx AB
IBUPROFEN
AMNEAL PHARMS NYANDA 0713351986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Rx AB
IBUPROFEN
PH HEALTHANDA 0712301986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0712311986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
PH HEALTHANDA 0712321986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
ADAPTISANDA 07126519862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
200MG TABLET ORAL Discontinued -
IBUPROFEN
CONTRACT PHARMACALANDA 07126819863 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Rx AB
400MG TABLET ORAL Rx AB
800MG TABLET ORAL Rx AB
IBUPROFEN
LEINERANDA 0712661986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MG TABLET ORAL Discontinued -
IBUPROFEN
PUREPAC PHARMANDA 0711221986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SUN PHARM INDUSTRIESANDA 0714621986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SUN PHARM INDUSTRIESANDA 0709081986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
STRIDES PHARMA INTLANDA 0704811986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
IVAX SUB TEVA PHARMSANDA 0711451986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
IVAX SUB TEVA PHARMSANDA 0711461986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
LEDERLEANDA 0706291986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
LEDERLEANDA 0706301986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
P AND L DEV LLCANDA 0707331986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
PUREPAC PHARMANDA 0711231986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MG TABLET ORAL Discontinued -
IBUPROFEN
PUREPAC PHARMANDA 0711241986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
PUREPAC PHARMANDA 0711251986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
ABBOTTANDA 0712641986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
STRIDES PHARMA INTLANDA 0709861986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBU
BASFANDA 0707451986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
800MG TABLET ORAL Discontinued -
IBUPROFEN
OHMANDA 0711631986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
MEDIPREN
MCNEILANDA 0712151986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
J AND J CONSUMER INCANDA 0700811986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
MCNEILANDA 0704761986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
RISINGANDA 07073619863 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
300MG TABLET ORAL Discontinued -
400MG TABLET ORAL Discontinued -
IBUPROFEN
SUPERPHARMANDA 0707091986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0704351986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
MEDIPREN
MCNEILANDA 0704751986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
OHM LABSANDA 0708181985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
SUN PHARM INDUSTRIESANDA 0704931985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
IBUPROFEN
SENORES PHARMSANDA 0700451985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
SENORES PHARMSANDA 0700571985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0700381985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0700411985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROHM
OHM LABSANDA 0704691985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0704361985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
WATSON LABSANDA 0704371985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
PAR PHARMANDA 0703281985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MG TABLET ORAL Discontinued -
IBUPROFEN
STRIDES PHARMA INTLANDA 0703291985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
STRIDES PHARMA INTLANDA 0703301985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
SUN PHARM INDUSTRIESANDA 0700791985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBUPROFEN
SUN PHARM INDUSTRIESANDA 0700801985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBUPROFEN
ABBOTTANDA 0705561985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBU
BASFANDA 0700991985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -
IBU
BASFANDA 0700831985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG TABLET ORAL Discontinued -
IBU
BASFANDA 0700881985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
600MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/ML	SUSPENSION/DROPS	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/ML	SUSPENSION/DROPS	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/1.25ML	SUSPENSION/DROPS	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/ML	SUSPENSION/DROPS	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG	TABLET	ORAL	Discontinued	-
600MG	TABLET	ORAL	Discontinued	-
800MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/5ML	SUSPENSION	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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NPPNew patient population exclusivity (3 years)
May 11, 2026
6 mo ago

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9114068	Sep 30, 2029	in 3 yr	U-1735
8735452	Sep 30, 2029	in 3 yr	U-981
9649284	Sep 30, 2029	in 3 yr	U-2018
8871810	Sep 30, 2029	in 3 yr	U-981
9295639	Sep 30, 2029	in 3 yr	U-1756
9138404	Sep 30, 2029	in 3 yr	U-1756
9012508	Sep 14, 2030	in 3 yr 11 mo	U-981
11806400	Mar 16, 2032	in 5 yr 6 mo	U-3746
9072661	Mar 16, 2032	in 5 yr 6 mo	U-2264
9072710	Mar 16, 2032	in 5 yr 6 mo	U-2266

Approval history

FDA approval span

Ask AI

First approval

Mar 05, 1984

43 yr 3 mo ago

Most recent approval

Jul 22, 2026

3 mo ago

Approvals span 1984–2026 across 208 FDA applications.

Brand (NDA) 2211%

Generic (ANDA) 18689%

Ibuprofen: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Ibuprofen

Key facts

Active ingredient: Ibuprofen
Brand (NDA): 22
Generic (ANDA): 186
Reference-listed drug: CALDOLOR
Dosage forms: CAPSULE, SOLUTION, SUSPENSION, SUSPENSION/DROPS, TABLET, TABLET, CHEWABLE
Routes: INTRAVENOUS, ORAL
TE codes: AB
Earliest patent expiry: Sep 30, 2029
Latest exclusivity: May 11, 2026