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FDA Orange Book · active-ingredient family

Clindamycin hydrochloride

Clindamycin hydrochloride is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CLEOCIN HYDROCHLORIDE · NDA 050162

1

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
CLEOCIN HYDROCHLORIDERLD×3PFIZERNDA 050162ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
CLINDAMYCIN HYDROCHLORIDE×3GLENMARK PHARMS LTDANDA 216957ABMar 10, 2023
CLINDAMYCIN HYDROCHLORIDE×3MICRO LABSANDA 207402ABNov 05, 2018
CLINDAMYCIN HYDROCHLORIDE×3PHARMOBEDIENTANDA 091225—May 31, 2011
CLINDAMYCIN HYDROCHLORIDE×2AUROBINDO PHARMAANDA 065442ABAug 26, 2009
CLINDAMYCIN HYDROCHLORIDE×3CHARTWELL MOLECULARANDA 065243ABAug 12, 2005
CLINDAMYCIN HYDROCHLORIDE×3ZYDUS PHARMS USAANDA 065217ABJan 31, 2005
CLINDAMYCIN HYDROCHLORIDE×2EPIC PHARMA LLCANDA 065194ABMar 22, 2004
CLINDAMYCIN HYDROCHLORIDE×2SUN PHARM INDS LTDANDA 065061ABFeb 02, 2001
CLINDAMYCIN HYDROCHLORIDEWATSON LABSANDA 063082—Jul 31, 1991
CLINDAMYCIN HYDROCHLORIDE×2WATSON LABSANDA 063083—Jul 31, 1991
CLINDAMYCIN HYDROCHLORIDE×2COSETTEANDA 063029—Sep 20, 1989
CLINDAMYCIN HYDROCHLORIDETEVAANDA 063027—Sep 20, 1989
CLEOCIN×2PHARMACIA AND UPJOHNANDA 061809—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Clindamycin hydrochloride — 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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