Lincomycin hydrochloride
Lincomycin hydrochloride: 2 brands, 6 generics; first approved Apr 16, 1991; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
- PFIZERNDA 050317—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION Rx AP - PHARMACIA AND UPJOHNNDA 050316—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued —
Generic (ANDA) products (6)
- LINCOMYCIN HYDROCHLORIDEHAINAN POLYANDA 2166622022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION Discontinued — - LINCOMYCIN HYDROCHLORIDEGLANDANDA 2156572022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION Rx AP - LINCOMYCIN HYDROCHLORIDEMICRO LABSANDA 2150822021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION Rx AP - LINCOMYCIN HYDROCHLORIDEARTHUR GRPANDA 2127702021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION Rx AP - LINCOMYCIN HYDROCHLORIDEXGEN PHARMSANDA 2017462015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION Rx AP - LINCOMYCIN HYDROCHLORIDESLAYBACKANDA 0631801991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/ML INJECTABLE INJECTION 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 1991–2022 across 8 FDA applications.
Lincomycin 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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