Gentamicin Sulfate

ANDA 62318, held by Watson Labs. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62318 (Gentamicin Sulfate), held by Watson Labs, was first approved by FDA on Aug 20, 1981, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 20, 1981
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 20, 1981	Original application	Approved	None posted

Products

2 strengths and forms


Gentamicin SulfateEQ 40MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 10MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 18Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 17Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 16Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 15Labeling	Approved	None posted
May 24, 1991	Supplement 11Labeling	Approved	None posted
May 24, 1991	Supplement 12Labeling	Approved	None posted
May 24, 1991	Supplement 13Labeling	Approved	None posted
May 24, 1991	Supplement 14Labeling	Approved	None posted
Nov 16, 1988	Supplement 10Manufacturing	Approved	None posted
Aug 20, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 62318
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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