Lincomycin Hydrochloride

ANDA 63180, held by Slayback. Lincomycin Hydrochloride.

As of Nov 15, 2026, ANDA 63180 (Lincomycin Hydrochloride), held by Slayback, was first approved by FDA on Apr 16, 1991, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1991
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 16, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lincomycin HydrochlorideEQ 300MG BASE/ML · injectable;injection	Lincomycin Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 7Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 6Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 5Manufacturing	Approved	None posted
May 7, 1996	Supplement 4Manufacturing	Approved	None posted
Sep 8, 1993	Supplement 3Labeling	Approved	None posted
Apr 16, 1992	Supplement 2Manufacturing	Approved	None posted
Jun 10, 1991	Supplement 1Labeling	Approved	None posted
Apr 16, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 63180
Drugs@FDA: Overview at FDA
Company: Slayback Pharma

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