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 Latest exclusivity ends
Brands (NDA)
15
Generics (ANDA)
74
Listed patents
3
Next patent expiry
Dec 02, 2026
in 3 mo
Brand (NDA) products
Originator applications
- ORGANON LLCNDA 2156502021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE GEL VAGINAL Rx — - 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 — - PADAGIS USNDA 0507932004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE CREAM VAGINAL Rx — - EVOCLINRLDNORVIUM BIOSCIENCENDA 0508012004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% AEROSOL, FOAM TOPICAL Discontinued — - BAUSCHNDA 0507822000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB2 - PFIZERNDA 0507671999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG SUPPOSITORY VAGINAL Rx — - 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 - ABRAXIS PHARMNDA 0506351989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 900MG BASE/100ML INJECTABLE INJECTION Rx — - 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 — - PFIZERNDA 0506001989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE LOTION TOPICAL Rx AB - PFIZERNDA 0506151987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - PFIZERNDA 050441—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP - CLEOCIN TRLDPFIZERNDA 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 — - 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 — - ABRAXIS PHARMNDA 0506361989
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
- CLINDAMYCIN PHOSPHATERISINGANDA 2183002026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEAUROBINDO PHARMA LTDANDA 2189422026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATECARNEGIEANDA 2196122025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SWAB TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEALEMBICANDA 2124662024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATEZYDUS LIFESCIENCESANDA 2165872023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - 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 PHOSPHATEAMNEALANDA 2152192022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEAMNEALANDA 2146682022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB2 - CLINDAMYCIN PHOSPHATEENCUBEANDA 2156072022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE LOTION TOPICAL Rx AB - CLINDAMYCIN PHOSPHATEGLENMARK PHARMS LTDANDA 2107782021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% AEROSOL, FOAM TOPICAL Rx AT - CLINDAMYCIN PHOSPHATESOLARIS PHARMA CORPANDA 2128422021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB2 - CLINDAMYCIN PHOSPHATESUN PHARMA CANADAANDA 2145262021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE LOTION TOPICAL Rx AB - CLINDAMYCIN PHOSPHATEENCUBEANDA 2124382021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATEPADAGIS ISRAELANDA 2146042021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE LOTION TOPICAL Rx AB - CLINDAMYCIN PHOSPHATEGLENMARK PHARMS LTDANDA 2142512021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATEPADAGIS ISRAELANDA 2121042020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATESUN PHARMA CANADAANDA 2140522020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATESOLARIS PHARMA CORPANDA 2118722020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATETAROANDA 2100042020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% AEROSOL, FOAM TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEENCUBE ETHICALSANDA 2099142019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEZYDUS LIFESCIENCESANDA 2087672018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - CLINDAMYCIN PHOSPHATECHARTWELL RXANDA 2098462018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - CLINDAMYCIN PHOSPHATERISINGANDA 2047482017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATERISINGANDA 2047492017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - 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 PHOSPHATEPAI HOLDINGS PHARMANDA 2069452016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEPH HEALTHANDA 2033432015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - 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 - 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 PHOSPHATESAGENT PHARMS INCANDA 0901082011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP - CLINDAMYCIN PHOSPHATESAGENT PHARMS INCANDA 0901092011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP - CLINDAMYCIN PHOSPHATEEPIC PHARMA LLCANDA 0655132010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SWAB TOPICAL Rx AT - CLINDAMYCIN PHOSPHATERSPADAGIS ISRAELANDA 0907852010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% AEROSOL, FOAM TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEFRESENIUS KABI USAANDA 0653472007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEFRESENIUS KABI USAANDA 0653462007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 0652542006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 0651392004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE CREAM VAGINAL Rx AB - CLINDAMYCIN PHOSPHATEHIKMAANDA 0652062004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP - CLINDAMYCIN PHOSPHATETARO PHARM INDSANDA 0651842004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 0650672002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE LOTION TOPICAL Rx AB - 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 PHOSPHATERSPADAGIS USANDA 0650492000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SWAB TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 0641602000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE GEL TOPICAL Rx AB1 - CLINDAMYCIN PHOSPHATEXTTRIUM LABS INCANDA 0633041997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEFOUGERA PHARMS INCANDA 0641591997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - PERRIGO COANDA 0641361996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SWAB TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEINGENUS PHARMS LLCANDA 0641081996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATERSPADAGIS USANDA 0640501995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Rx AT - CLINDAMYCIN PHOSPHATEBEDFORDANDA 0631631994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - PADAGIS USANDA 0633291992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATETEVA PARENTERALANDA 0632821992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEWATSON LABSANDA 0630791990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATETEVA PARENTERALANDA 0630411989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEHIKMAANDA 0630681989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEVINTAGE PHARMSANDA 0629301989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEIGI LABS INCANDA 0629281989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEBRISTOL MYERS SQUIBBANDA 0629081989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEBOCA PHARMA LLCANDA 0629441989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEMARSAM PHARMS LLCANDA 0629131988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEALMAJECTANDA 0629431988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEG AND W LABS INCANDA 0628111988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - CLINDAMYCIN PHOSPHATEWATSON LABSANDA 0629001988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEABRAXIS PHARMANDA 0627471988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATELOCHANDA 0629051988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEHIKMAANDA 0628891988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP - CLINDAMYCIN PHOSPHATEHIKMAANDA 0629531988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATESOLOPAKANDA 0628521988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATESOLOPAKANDA 0628191988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - PFIZERANDA 0628031987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Rx AP - CLINDAMYCIN PHOSPHATEHIKMAANDA 0628061987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEALMAJECTANDA 0628001987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - CLINDAMYCIN PHOSPHATEALMAJECTANDA 0628011987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/ML INJECTABLE INJECTION Discontinued — - PHARMACIA AND UPJOHNANDA 0623631982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION TOPICAL Discontinued — - 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
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
1 yr 9 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
in 3 yr 4 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9789057 | in 3 mo | ProductU-137 | |
| 11129896 | in 10 yr 3 mo | U-3293 | |
| 12303563 | in 10 yr 3 mo | Product |
Approval history
FDA approval span
First approval
45 yr 2 mo ago
Most recent approval
5 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

