Is there a generic for Metronidazole?

Yes. The FDA Orange Book lists 62 approved generic (ANDA) applications for Metronidazole, referencing the brand LIKMEZ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Metronidazole?

LIKMEZ (NDA 216755, SAPTALIS PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Metronidazole?

The Orange Book lists 9 patents against Metronidazole products, with the earliest listed expiry in 2028. 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.

What dosage forms of Metronidazole are approved?

Metronidazole is approved in the following dosage forms: capsule, cream, gel, injectable, lotion, suspension, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Metronidazole

Metronidazole: 29 brands, 62 generics; first approved Mar 04, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 62 ANDA applications approved.

Earliest patent expiry Feb 02, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 02, 2028

in 1 yr 4 mo

Brand (NDA) products

Originator applications

LIKMEZRLDRS
SAPTALIS PHARMSNDA 2167552023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/5ML SUSPENSION ORAL Rx —
NUVESSARLDRS
ALEMBIC THERAPNDA 2052232014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.3% GEL VAGINAL Rx —
METROGELRLDRS
GALDERMA LABS LPNDA 0217892005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Rx AB
METROLOTIONRLDRS
GALDERMA LABS LPNDA 0209011998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% LOTION TOPICAL Rx AB
FLAGYL ERRLD
PFIZERNDA 0208681997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
750MG TABLET, EXTENDED RELEASE ORAL Discontinued —
NORITATERLDRS
BAUSCHNDA 0207431997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx —
METROCREAMRLD
GALDERMA LABS LPNDA 0205311995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% CREAM TOPICAL Rx AB
FLAGYLRLDRS
PFIZERNDA 0203341995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
375MG CAPSULE ORAL Rx AB
METROGEL-VAGINALRLD
BAUSCHNDA 0202081992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Discontinued —
METROGELRLD
GALDERMA LABS LPNDA 0197371988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL TOPICAL Discontinued —
METRONIDAZOLE IN PLASTIC CONTAINERRLDRS
HOSPIRANDA 0188901983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Rx AP
METRO I.V. IN PLASTIC CONTAINERRLD
B BRAUNNDA 0189001983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
FLAGYL I.V. RTU IN PLASTIC CONTAINERRLDRS
BAXTER HLTHCARENDA 018657—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Rx AP
FLAGYLRLD
PFIZERNDA 012623—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
VANDAZOLERS
TEVA PHARMSNDA 0218062005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx BX
METRONIDAZOLE
LNKNDA 0190291984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METRONIDAZOLE
HIKMANDA 0189071984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
ABBOTTNDA 0188891983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
CHARTWELL MOLECULESNDA 0188451983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METRONIDAZOLE
CHARTWELL MOLECULESNDA 0189301983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
PROTOSTAT
ORTHO MCNEIL PHARMNDA 01887119832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
MUTUAL PHARMNDA 01881819832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
FOSUN PHARMANDA 01874019822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
WATSON LABSNDA 01859919822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
WATSON LABSNDA 01876419822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRO I.V.
B BRAUNNDA 0186741982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
FOSUN PHARMANDA 01862019822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
FLAGYL I.V. RTU IN PLASTIC CONTAINER
PFIZERNDA 018353—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
IVAX SUB TEVA PHARMSNDA 018517—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/5ML	SUSPENSION	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.3%	GEL	VAGINAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	LOTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
750MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	BX

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (62)

Abbreviated applications

METRONIDAZOLE
ZYDUS LIFESCIENCESANDA 2200952026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL TOPICAL Rx AB
METRONIDAZOLE
AUROBINDO PHARMA LTDANDA 2192952025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% CREAM TOPICAL Rx AB
METRONIDAZOLE
SCIEGEN PHARMSANDA 2167502024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx AB
METRONIDAZOLE
INNOGENIXANDA 07077220243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
125MG TABLET ORAL Rx —
METRONIDAZOLE
AUROBINDO PHARMA LTDANDA 2189412024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Rx AB
METRONIDAZOLE
ENCUBEANDA 2167952024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.3% GEL VAGINAL Discontinued —
METRONIDAZOLE
COSETTE PHARMS NCANDA 2163232023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx AB
METRONIDAZOLERS
ENCUBEANDA 2156102023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx AB
METRONIDAZOLE IN PLASTIC CONTAINER
AMNEALANDA 2176652023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Rx AP
METRONIDAZOLE
ZYDUS LIFESCIENCESANDA 2171282023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% CREAM TOPICAL Rx BX
METRONIDAZOLE
COSETTE PHARMS NCANDA 2166922023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Rx AB
METRONIDAZOLE
GLENMARK PHARMS LTDANDA 2157942022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx AB
METRONIDAZOLE
SOLARIS PHARMA CORPANDA 2136482021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx AB
METRONIDAZOLE
ALEMBICANDA 2126462021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Rx AB
METRONIDAZOLE IN PLASTIC CONTAINER
GLANDANDA 2124352020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Rx AP
METRONIDAZOLE
PADAGIS ISRAELANDA 2117862019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Rx AB
METRONIDAZOLE IN PLASTIC CONTAINERRS
INFORLIFEANDA 2061912019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Rx AP
METRONIDAZOLE
CADILA PHARMS LTDANDA 20979420172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE
LUPINANDA 20909620172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
ALEMBICANDA 20868120172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE IN PLASTIC CONTAINER
RISINGANDA 2055312017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
TAROANDA 2046512017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Rx AB
METRONIDAZOLE
CADILAANDA 20656020162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE
NOVITIUM PHARMAANDA 20816220162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE
FLAMINGO PHARMSANDA 20730920162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
SOMERSET THERAPS LLCANDA 20524520152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE
AUROBINDO PHARMA LTDANDA 20397420152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE
UNICHEMANDA 20345820142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE
CHARTWELL RXANDA 0909032011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Discontinued —
METRONIDAZOLERS
COSETTE PHARMS NCANDA 0781782011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL TOPICAL Rx AB
METRONIDAZOLE
ALEMBICANDA 0902222010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
750MG TABLET, EXTENDED RELEASE ORAL Discontinued —
METRONIDAZOLE
ALEMBICANDA 0790652009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
375MG CAPSULE ORAL Rx AB
METRONIDAZOLE
ALEMBIC PHARMS LTDANDA 07906720092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
500MG TABLET ORAL Rx AB
METRONIDAZOLE IN PLASTIC CONTAINER
BAXTER HLTHCARE CORPANDA 0780842008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
COSETTE PHARMS NCANDA 0775492007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% CREAM TOPICAL Rx AB
METRONIDAZOLE
ENCUBEANDA 0772642006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL VAGINAL Discontinued —
METRONIDAZOLE
TAROANDA 0778192006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL TOPICAL Rx AB
METRONIDAZOLE
ENCUBEANDA 0775472006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL TOPICAL Rx AB
METRONIDAZOLE
FOUGERA PHARMSANDA 0770182006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% GEL TOPICAL Rx AB
METRONIDAZOLE
FOUGERA PHARMSANDA 0771972006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% LOTION TOPICAL Rx AB
METRONIDAZOLERS
FOUGERA PHARMSANDA 0764082004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% CREAM TOPICAL Rx AB
METRONIDAZOLE
CHARTWELL RXANDA 0765222004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
375MG CAPSULE ORAL Rx AB
METRONIDAZOLE
ABLEANDA 0765052003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
375MG CAPSULE ORAL Discontinued —
METRONIDAZOLE
ABLEANDA 07651920032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
ABLEANDA 0764622003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
750MG TABLET, EXTENDED RELEASE ORAL Discontinued —
METROMIDOL
LABS AFANDA 07452319962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
SATRIC
SAVAGE LABSANDA 0707311987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
WATSON LABSANDA 0701701986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
HALSEYANDA 0705931986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
INTL MEDICATIONANDA 0700041985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
HALSEYANDA 0700211985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
SATRIC
SAVAGE LABSANDA 0700291985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METRONIDAZOLE
WATSON LABS INCANDA 0700441985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Rx AB
METRONIDAZOLE
STRIDES PHARMAANDA 0700401985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METRONIDAZOLE
STRIDES PHARMAANDA 0700391985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
WATSON LABSANDA 0700421984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
WATSON LABSANDA 0700351984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
METRONIDAZOLE
SUPERPHARMANDA 0700081984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METRONIDAZOLE
SUPERPHARMANDA 0700091984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METRONIDAZOLE
PLIVAANDA 0700331984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Rx AB
METRONIDAZOLE
ABRAXIS PHARMANDA 0700711984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/100ML INJECTABLE INJECTION Discontinued —
METRONIDAZOLE
TEVA PHARMS USAANDA 0700271984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB
125MG	TABLET	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.3%	GEL	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	CREAM	TOPICAL	Rx	BX

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	GEL	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8877792	Feb 02, 2028	in 1 yr 4 mo	Product
7893097	Feb 19, 2028	in 1 yr 5 mo	Product
8658678	Jun 27, 2028	in 1 yr 9 mo	U-1682
9198858	Jun 28, 2032	in 5 yr 10 mo	U-1664
8946276	Jun 28, 2032	in 5 yr 10 mo	U-1664
10238634	Jun 28, 2032	in 5 yr 10 mo	Product
10596155	Jun 28, 2032	in 5 yr 10 mo	Product
12257236	Jan 16, 2039	in 12 yr 5 mo	ProductU-3169
11541035	Oct 04, 2039	in 13 yr 2 mo	Product

Approval history

FDA approval span

First approval

Mar 04, 1982

45 yr 3 mo ago

Most recent approval

Feb 13, 2026

8 mo ago

Approvals span 1982–2026 across 91 FDA applications.

Brand (NDA) 2932%

Generic (ANDA) 6268%

Metronidazole: 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.

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