Gentamicin Sulfate

ANDA 62427, held by Sun Pharma Canada. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62427 (Gentamicin Sulfate), held by Sun Pharma Canada, was first approved by FDA on May 26, 1983, with 19 approved supplements and 0 published complete response letters.

First approved: May 26, 1983
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
May 26, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 0.1% BASE · cream;topical	Gentamicin Sulfate	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jul 5, 1996	Supplement 39Labeling	Approved	None posted
Jul 5, 1996	Supplement 38Manufacturing	Approved	None posted
Sep 16, 1992	Supplement 37Labeling	Approved	None posted
Aug 27, 1992	Supplement 36Labeling	Approved	None posted
Jun 26, 1992	Supplement 34Labeling	Approved	None posted
Apr 22, 1992	Supplement 33Labeling	Approved	None posted
Jul 30, 1991	Supplement 30Manufacturing	Approved	None posted
Apr 26, 1991	Supplement 32Labeling	Approved	None posted
Apr 15, 1991	Supplement 29Labeling	Approved	None posted
Apr 15, 1991	Supplement 27Labeling	Approved	None posted
Jul 24, 1989	Supplement 28Manufacturing	Approved	None posted
Nov 16, 1988	Supplement 26Manufacturing	Approved	None posted
Jul 9, 1987	Supplement 24Manufacturing	Approved	None posted
Jul 3, 1986	Supplement 23Manufacturing	Approved	None posted
Feb 14, 1986	Supplement 22Manufacturing	Approved	None posted
Feb 10, 1986	Supplement 21Manufacturing	Approved	None posted
Nov 25, 1985	Supplement 20Manufacturing	Approved	None posted
Sep 16, 1985	Supplement 19Manufacturing	Approved	None posted
May 20, 1985	Supplement 18Manufacturing	Approved	None posted
May 26, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62427
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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