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FDA Orange Book · active-ingredient family

Clindamycin phosphate

Clindamycin phosphate is approved as 15 brand and 74 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XACIATO · NDA 215650

15

Brand (NDA)

74

Generics (ANDA)

3

Listed patents

2

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream, gel, injectable, lotion, solution, suppository, swab

ProductApplicantApplicationTEApproved
XACIATORLDORGANON LLCNDA 215650—Dec 07, 2021
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDERLD×3BAXTER HLTHCARE CORPNDA 208083—Apr 20, 2017
CLINDESSERLDPADAGIS USNDA 050793—Nov 30, 2004
EVOCLINRLDNORVIUM BIOSCIENCENDA 050801—Oct 22, 2004
CLINDAGELRLDBAUSCHNDA 050782AB2Nov 27, 2000
CLEOCINRLDPFIZERNDA 050767—Aug 13, 1999
CLEOCINRLD×2PFIZERNDA 050680ABMar 02, 1998
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%RLDABRAXIS PHARMNDA 050635—Dec 22, 1989
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×3PFIZERNDA 050639—Aug 30, 1989
CLEOCIN TRLDPFIZERNDA 050600ABMay 31, 1989
CLEOCIN TRLDPFIZERNDA 050615AB1Jan 07, 1987
CLEOCIN PHOSPHATERLDPFIZERNDA 050441APApproved Prior to Jan 1, 1982
CLEOCIN TRLD×2PFIZERNDA 050537—Approved Prior to Jan 1, 1982
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER×3BAXTER HLTHCARENDA 050648—Dec 29, 1989
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%ABRAXIS PHARMNDA 050636—Dec 22, 1989

Generic (ANDA) products (74)

ProductApplicantApplicationTEApproved
CLINDAMYCIN PHOSPHATERISINGANDA 218300ATMar 23, 2026
CLINDAMYCIN PHOSPHATEAUROBINDO PHARMA LTDANDA 218942AB1Mar 18, 2026
CLINDAMYCIN PHOSPHATECARNEGIEANDA 219612ATJun 13, 2025
CLINDAMYCIN PHOSPHATEALEMBICANDA 212466AB1Apr 02, 2024
CLINDAMYCIN PHOSPHATEZYDUS LIFESCIENCESANDA 216587AB1Sep 19, 2023
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%×3HIKMAANDA 214401APApr 05, 2023
CLINDAMYCIN PHOSPHATEAMNEALANDA 215219—Nov 03, 2022
CLINDAMYCIN PHOSPHATEAMNEALANDA 214668AB2Aug 05, 2022
CLINDAMYCIN PHOSPHATEENCUBEANDA 215607ABJan 18, 2022
CLINDAMYCIN PHOSPHATEGLENMARK PHARMS LTDANDA 210778ATSep 20, 2021
CLINDAMYCIN PHOSPHATESOLARIS PHARMA CORPANDA 212842AB2Aug 13, 2021
CLINDAMYCIN PHOSPHATESUN PHARMA CANADAANDA 214526ABJun 28, 2021
CLINDAMYCIN PHOSPHATEENCUBEANDA 212438AB1Mar 11, 2021
CLINDAMYCIN PHOSPHATEPADAGIS ISRAELANDA 214604ABMar 08, 2021
CLINDAMYCIN PHOSPHATEGLENMARK PHARMS LTDANDA 214251AB1Feb 10, 2021
CLINDAMYCIN PHOSPHATEPADAGIS ISRAELANDA 212104AB1Dec 31, 2020
CLINDAMYCIN PHOSPHATESUN PHARMA CANADAANDA 214052AB1Nov 10, 2020
CLINDAMYCIN PHOSPHATESOLARIS PHARMA CORPANDA 211872AB1Jul 29, 2020
CLINDAMYCIN PHOSPHATETAROANDA 210004ATMar 11, 2020
CLINDAMYCIN PHOSPHATEENCUBE ETHICALSANDA 209914ATJan 28, 2019
CLINDAMYCIN PHOSPHATEZYDUS LIFESCIENCESANDA 208767ATJul 16, 2018
CLINDAMYCIN PHOSPHATECHARTWELL RXANDA 209846ATFeb 08, 2018
CLINDAMYCIN PHOSPHATERISINGANDA 204748—Oct 10, 2017
CLINDAMYCIN PHOSPHATERISINGANDA 204749—Oct 10, 2017
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER×3BAXTER HLTHCARE CORPANDA 208084APJun 28, 2017
CLINDAMYCIN PHOSPHATEPAI HOLDINGS PHARMANDA 206945—Dec 30, 2016
CLINDAMYCIN PHOSPHATEPH HEALTHANDA 203343—May 29, 2015
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER×3RISINGANDA 203048APApr 04, 2013
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER×3SANDOZ INCANDA 201692APMay 31, 2012
CLINDAMYCIN PHOSPHATESAGENT PHARMS INCANDA 090108APSep 30, 2011
CLINDAMYCIN PHOSPHATESAGENT PHARMS INCANDA 090109APSep 30, 2011
CLINDAMYCIN PHOSPHATEEPIC PHARMA LLCANDA 065513ATJun 17, 2010
CLINDAMYCIN PHOSPHATEPADAGIS ISRAELANDA 090785ATMar 31, 2010
CLINDAMYCIN PHOSPHATEFRESENIUS KABI USAANDA 065347—May 09, 2007
CLINDAMYCIN PHOSPHATEFRESENIUS KABI USAANDA 065346—Mar 29, 2007
CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 065254—Feb 14, 2006
CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 065139ABDec 27, 2004
CLINDAMYCIN PHOSPHATEHIKMAANDA 065206APSep 24, 2004
CLINDAMYCIN PHOSPHATETARO PHARM INDSANDA 065184ATMar 31, 2004
CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 065067ABJan 31, 2002
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER×3ABBOTT LABSANDA 065027—Jun 29, 2001
CLINDAMYCIN PHOSPHATEPADAGIS USANDA 065049ATMay 25, 2000
CLINDAMYCIN PHOSPHATEFOUGERA PHARMSANDA 064160AB1Jan 28, 2000
CLINDAMYCIN PHOSPHATEXTTRIUM LABS INCANDA 063304—Jul 15, 1997
CLINDAMYCIN PHOSPHATEFOUGERA PHARMS INCANDA 064159ATJun 05, 1997
CLINDETSPERRIGO COANDA 064136—Sep 30, 1996
CLINDAMYCIN PHOSPHATEINGENUS PHARMS LLCANDA 064108—Sep 27, 1996
CLINDAMYCIN PHOSPHATEPADAGIS USANDA 064050ATNov 30, 1995
CLINDAMYCIN PHOSPHATEBEDFORDANDA 063163—Jun 30, 1994
CLINDA-DERMPADAGIS USANDA 063329—Sep 30, 1992
CLINDAMYCIN PHOSPHATETEVA PARENTERALANDA 063282—May 29, 1992
CLINDAMYCIN PHOSPHATEWATSON LABSANDA 063079—Mar 05, 1990
CLINDAMYCIN PHOSPHATETEVA PARENTERALANDA 063041—Dec 29, 1989
CLINDAMYCIN PHOSPHATEHIKMAANDA 063068—Aug 28, 1989
CLINDAMYCIN PHOSPHATEVINTAGE PHARMSANDA 062930—Jun 28, 1989
CLINDAMYCIN PHOSPHATEIGI LABS INCANDA 062928—Feb 13, 1989
CLINDAMYCIN PHOSPHATEBRISTOL MYERS SQUIBBANDA 062908—Feb 01, 1989
CLINDAMYCIN PHOSPHATEBOCA PHARMA LLCANDA 062944—Jan 11, 1989
CLINDAMYCIN PHOSPHATEMARSAM PHARMS LLCANDA 062913—Oct 20, 1988
CLINDAMYCIN PHOSPHATEALMAJECTANDA 062943—Sep 29, 1988
CLINDAMYCIN PHOSPHATEG AND W LABS INCANDA 062811—Sep 01, 1988
CLINDAMYCIN PHOSPHATEWATSON LABSANDA 062900—Jun 08, 1988
CLINDAMYCIN PHOSPHATEABRAXIS PHARMANDA 062747—Jun 03, 1988
CLINDAMYCIN PHOSPHATELOCHANDA 062905—May 09, 1988
CLINDAMYCIN PHOSPHATEHIKMAANDA 062889APApr 25, 1988
CLINDAMYCIN PHOSPHATEHIKMAANDA 062953—Apr 21, 1988
CLINDAMYCIN PHOSPHATESOLOPAKANDA 062852—Mar 17, 1988
CLINDAMYCIN PHOSPHATESOLOPAKANDA 062819—Mar 15, 1988
CLEOCIN PHOSPHATEPFIZERANDA 062803APOct 16, 1987
CLINDAMYCIN PHOSPHATEHIKMAANDA 062806—Oct 15, 1987
CLINDAMYCIN PHOSPHATEALMAJECTANDA 062800—Jul 24, 1987
CLINDAMYCIN PHOSPHATEALMAJECTANDA 062801—Jul 24, 1987
CLEOCIN TPHARMACIA AND UPJOHNANDA 062363—Feb 08, 1982
CLEOCIN PHOSPHATEPHARMACIA AND UPJOHNANDA 061839—Approved Prior to Jan 1, 1982

Marketing exclusivity (2)

  • NPNew product exclusivity (3 years)

    Dec 07, 2024

    1 yr 7 mo ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Dec 07, 2029

    in 3 yr 6 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9789057Dec 02, 2026in 6 mo
ProductU-137
11129896Sep 22, 2036in 10 yr 5 mo
U-3293
12303563Sep 22, 2036in 10 yr 5 mo
Product

Clindamycin phosphate — frequently asked questions

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

Agent CTA Background

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