Is there a generic for Clindamycin phosphate?

Yes. The FDA Orange Book lists 74 approved generic (ANDA) applications for Clindamycin phosphate, referencing the brand XACIATO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clindamycin phosphate?

XACIATO (NDA 215650, ORGANON LLC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Clindamycin phosphate?

The Orange Book lists 3 patents against Clindamycin phosphate products, with the earliest listed expiry in 2026. 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 Clindamycin phosphate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Clindamycin phosphate. 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 Clindamycin phosphate are approved?

Clindamycin phosphate is approved in the following dosage forms: aerosol, foam, cream, gel, injectable, lotion, solution, suppository, swab.

FDA Orange Book · active-ingredient family

Clindamycin phosphate

Clindamycin phosphate: 15 brands, 74 generics; first approved Feb 08, 1982; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 74 ANDA applications approved.

Earliest patent expiry Dec 02, 2026Latest exclusivity ends Dec 07, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 02, 2026

in 1 mo

Brand (NDA) products

Originator applications

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XACIATORLDRS
ORGANON LLCNDA 2156502021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2% BASE GEL VAGINAL Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2% BASE	GEL	VAGINAL	Rx	-

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDERLDRS

BAXTER HLTHCARE CORPNDA 20808320173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 300MG BASE/50ML (EQ 6MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	-
EQ 600MG BASE/50ML (EQ 12MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	-
EQ 900MG BASE/50ML (EQ 18MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	-

CLINDESSERLDRS
PADAGIS USNDA 0507932004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2% BASE CREAM VAGINAL Rx -
EVOCLINRLD
QUAGENNDA 0508012004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% AEROSOL, FOAM TOPICAL Discontinued -
CLINDAGELRLDRS
BAUSCHNDA 0507822000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB2
CLEOCINRLDRS
PFIZERNDA 0507671999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG SUPPOSITORY VAGINAL Rx -
CLEOCINRLD
PFIZERNDA 05068019982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2% BASE CREAM VAGINAL Discontinued -
EQ 2% BASE CREAM VAGINAL Rx AB
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%RLDRS
ABRAXIS PHARMNDA 0506351989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 900MG BASE/100ML INJECTABLE INJECTION Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2% BASE	CREAM	VAGINAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	AEROSOL, FOAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB2

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	SUPPOSITORY	VAGINAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2% BASE	CREAM	VAGINAL	Discontinued	-
EQ 2% BASE	CREAM	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 900MG BASE/100ML	INJECTABLE	INJECTION	Rx	-

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD

PFIZERNDA 05063919893 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 18MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

CLEOCIN TRLDRS
PFIZERNDA 0506001989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE LOTION TOPICAL Rx AB
CLEOCIN TRLDRS
PFIZERNDA 0506151987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLEOCIN PHOSPHATERLDRS
PFIZERNDA 050441-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP
CLEOCIN TRLD
PFIZERNDA 050537-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
EQ 1% BASE SWAB TOPICAL Discontinued -

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SOLUTION	TOPICAL	Discontinued	-
EQ 1% BASE	SWAB	TOPICAL	Discontinued	-

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARENDA 05064819893 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 900MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
ABRAXIS PHARMNDA 0506361989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12MG BASE/ML INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Generic (ANDA) products (74)

Abbreviated applications

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CLINDAMYCIN PHOSPHATE
RISINGANDA 2183002026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SWAB TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
AUROBINDO PHARMA LTDANDA 2189422026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
CARNEGIEANDA 2196122025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SWAB TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
ALEMBICANDA 2124662024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
ZYDUS LIFESCIENCESANDA 2165872023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
HIKMAANDA 21440120233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 6MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 12MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 18MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
AMNEALANDA 2152192022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
AMNEALANDA 2146682022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB2
CLINDAMYCIN PHOSPHATE
ENCUBEANDA 2156072022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE LOTION TOPICAL Rx AB
CLINDAMYCIN PHOSPHATE
GLENMARK PHARMS LTDANDA 2107782021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% AEROSOL, FOAM TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
SOLARIS PHARMA CORPANDA 2128422021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB2
CLINDAMYCIN PHOSPHATE
SUN PHARMA CANADAANDA 2145262021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE LOTION TOPICAL Rx AB
CLINDAMYCIN PHOSPHATE
ENCUBEANDA 2124382021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
PADAGIS ISRAELANDA 2146042021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE LOTION TOPICAL Rx AB
CLINDAMYCIN PHOSPHATE
GLENMARK PHARMS LTDANDA 2142512021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
PADAGIS ISRAELANDA 2121042020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
SUN PHARMA CANADAANDA 2140522020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
SOLARIS PHARMA CORPANDA 2118722020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
TAROANDA 2100042020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% AEROSOL, FOAM TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
ENCUBE ETHICALSANDA 2099142019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
ZYDUS LIFESCIENCESANDA 2087672018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
CHARTWELL RXANDA 2098462018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
RISINGANDA 2047482017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
RISINGANDA 2047492017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
BAXTER HLTHCARE CORPANDA 20808420173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 6MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 12MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 18MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
PAI HOLDINGS PHARMANDA 2069452016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
PH HEALTHANDA 2033432015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
RISINGANDA 20304820133 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 6MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 12MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 18MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERRS
SANDOZ INCANDA 20169220123 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 6MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 12MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 18MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
SAGENT PHARMS INCANDA 0901082011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
SAGENT PHARMS INCANDA 0901092011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
EPIC PHARMA LLCANDA 0655132010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SWAB TOPICAL Rx AT
CLINDAMYCIN PHOSPHATERS
PADAGIS ISRAELANDA 0907852010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% AEROSOL, FOAM TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
FRESENIUS KABI USAANDA 0653472007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
FRESENIUS KABI USAANDA 0653462007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
FOUGERA PHARMSANDA 0652542006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATERS
FOUGERA PHARMSANDA 0651392004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2% BASE CREAM VAGINAL Rx AB
CLINDAMYCIN PHOSPHATE
HIKMAANDA 0652062004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
TARO PHARM INDSANDA 0651842004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
FOUGERA PHARMSANDA 0650672002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE LOTION TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SWAB	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SWAB	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 18MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB2

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	AEROSOL, FOAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB2

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	GEL	TOPICAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	AEROSOL, FOAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 18MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 18MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 18MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1% BASE	SWAB	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	AEROSOL, FOAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT LABSANDA 06502720013 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 12MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 18MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

CLINDAMYCIN PHOSPHATERS
PADAGIS USANDA 0650492000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SWAB TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
FOUGERA PHARMSANDA 0641602000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE GEL TOPICAL Rx AB1
CLINDAMYCIN PHOSPHATE
XTTRIUM LABS INCANDA 0633041997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
FOUGERA PHARMS INCANDA 0641591997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Rx AT
CLINDETS
PERRIGO COANDA 0641361996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SWAB TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
INGENUS PHARMS LLCANDA 0641081996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATERS
PADAGIS USANDA 0640501995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Rx AT
CLINDAMYCIN PHOSPHATE
BEDFORDANDA 0631631994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDA-DERM
PADAGIS USANDA 0633291992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
TEVA PARENTERALANDA 0632821992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
WATSON LABSANDA 0630791990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
TEVA PARENTERALANDA 0630411989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
HIKMAANDA 0630681989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
VINTAGE PHARMSANDA 0629301989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
IGI LABS INCANDA 0629281989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
BRISTOL MYERS SQUIBBANDA 0629081989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
BOCA PHARMA LLCANDA 0629441989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
MARSAM PHARMS LLCANDA 0629131988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
ALMAJECTANDA 0629431988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
G AND W LABS INCANDA 0628111988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLINDAMYCIN PHOSPHATE
WATSON LABSANDA 0629001988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
ABRAXIS PHARMANDA 0627471988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
LOCHANDA 0629051988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
HIKMAANDA 0628891988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
HIKMAANDA 0629531988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
SOLOPAKANDA 0628521988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
SOLOPAKANDA 0628191988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLEOCIN PHOSPHATE
PFIZERANDA 0628031987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP
CLINDAMYCIN PHOSPHATE
HIKMAANDA 0628061987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
ALMAJECTANDA 0628001987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLINDAMYCIN PHOSPHATE
ALMAJECTANDA 0628011987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -
CLEOCIN T
PHARMACIA AND UPJOHNANDA 0623631982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1% BASE SOLUTION TOPICAL Discontinued -
CLEOCIN PHOSPHATE
PHARMACIA AND UPJOHNANDA 061839-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued -

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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NPNew product exclusivity (3 years)
Dec 07, 2024
1 yr 11 mo ago
GAINQualified infectious disease product exclusivity (adds 5 years)
Dec 07, 2029
in 3 yr 2 mo

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
9789057	Dec 02, 2026	in 1 mo	ProductU-137
11129896	Sep 22, 2036	in 10 yr 1 mo	U-3293
12303563	Sep 22, 2036	in 10 yr 1 mo	Product

Approval history

FDA approval span

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First approval

Feb 08, 1982

45 yr 4 mo ago

Most recent approval

Mar 23, 2026

7 mo ago

Approvals span 1982–2026 across 89 FDA applications.

Brand (NDA) 1517%

Generic (ANDA) 7483%

Clindamycin phosphate: 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 Clindamycin phosphate

Key facts

Active ingredient: Clindamycin phosphate
Brand (NDA): 15
Generic (ANDA): 74
Reference-listed drug: XACIATO
Dosage forms: AEROSOL, FOAM, CREAM, GEL, INJECTABLE, LOTION, SOLUTION, SUPPOSITORY, SWAB
Routes: INJECTION, INTRAVENOUS, TOPICAL, VAGINAL
TE codes: AB, AB1, AB2, AP, AT
Earliest patent expiry: Dec 02, 2026
Latest exclusivity: Dec 07, 2029