Clindamycin palmitate hydrochloride
Clindamycin palmitate hydrochloride: 0 brands, 9 generics; first approved Apr 07, 1986; generic available.
Generic available: 9 ANDA applications approved.
Generic (ANDA) products (9)
- CLINDAMYCIN PALMITATE HYDROCHLORIDEAPPCOANDA 2070472018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Rx AA - CLINDAMYCIN PALMITATE HYDROCHLORIDECHARTWELL RXANDA 2069582017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Rx AA - CLINDAMYCIN PALMITATE HYDROCHLORIDEEXTROVISANDA 2030632016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Discontinued — - CLINDAMYCIN PALMITATE HYDROCHLORIDEAMNEAL PHARMSANDA 2035132014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Discontinued — - CLINDAMYCIN PALMITATE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2024092013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Rx AA - CLINDAMYCIN PALMITATE HYDROCHLORIDERISINGANDA 2018212012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Rx AA - CLINDAMYCIN PALMITATE HYDROCHLORIDEPADAGIS USANDA 0909022010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Discontinued — - CLEOCINRSPFIZERANDA 0626441986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Rx AA - PHARMACIA AND UPJOHNANDA 061827—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/5ML FOR SOLUTION ORAL Discontinued —
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.
Approval history
Approvals span 1986–2018 across 9 FDA applications.
Clindamycin palmitate 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.
