Treats serious infections due to susceptible strains of streptococci, pneumococci, and…. ANDA 215082, held by Micro Labs. Lincomycin Hydrochloride.
As of Nov 15, 2026, ANDA 215082 (Lincomycin Hydrochloride), held by Micro Labs, was first approved by FDA on Nov 8, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Lincomycin injection is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lincomycin HydrochlorideEQ 300MG BASE/ML · injectable;injection | Lincomycin Hydrochloride | Rx |
| Feb 6, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 8, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
