FDA Orange Book · active-ingredient family
Clindamycin hydrochloride
Clindamycin hydrochloride: 1 brand, 13 generics; first approved Apr 14, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- PFIZERNDA 050162-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (13)
Abbreviated applications
- CLINDAMYCIN HYDROCHLORIDEGLENMARK PHARMS LTDANDA 21695720233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - CLINDAMYCIN HYDROCHLORIDEMICRO LABSANDA 20740220183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - CLINDAMYCIN HYDROCHLORIDEPHARMOBEDIENTANDA 09122520113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Discontinued - EQ 150MG BASE CAPSULE ORAL Discontinued - EQ 300MG BASE CAPSULE ORAL Discontinued - - CLINDAMYCIN HYDROCHLORIDEAUROBINDO PHARMAANDA 06544220092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - CLINDAMYCIN HYDROCHLORIDECHARTWELL MOLECULARANDA 06524320053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued - EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Discontinued - - CLINDAMYCIN HYDROCHLORIDEZYDUS PHARMS USAANDA 06521720053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - CLINDAMYCIN HYDROCHLORIDEEPIC PHARMA LLCANDA 06519420042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - CLINDAMYCIN HYDROCHLORIDESUN PHARM INDS LTDANDA 06506120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - CLINDAMYCIN HYDROCHLORIDEWATSON LABSANDA 0630821991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Discontinued - - CLINDAMYCIN HYDROCHLORIDEWATSON LABSANDA 06308319912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued - EQ 300MG BASE CAPSULE ORAL Discontinued - - CLINDAMYCIN HYDROCHLORIDECOSETTE PHARMS NCANDA 06302919892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued - EQ 300MG BASE CAPSULE ORAL Discontinued - - CLINDAMYCIN HYDROCHLORIDETEVAANDA 0630271989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Discontinued - - PHARMACIA AND UPJOHNANDA 061809-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Discontinued - EQ 150MG BASE CAPSULE ORAL Discontinued -
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
39 yr 1 mo ago
Most recent approval
3 yr 8 mo ago
Approvals span 1988–2023 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Clindamycin hydrochloride: 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.
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