Gentamicin Sulfate

ANDA 62635, held by Epic Pharma LLC. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62635 (Gentamicin Sulfate), held by Epic Pharma LLC, was first approved by FDA on Jan 8, 1987, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 8, 1987
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 8, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 0.3% BASE · solution/drops;ophthalmic	Gentamicin Sulfate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Mar 8, 2002	Supplement 14Manufacturing	Approved	None posted
Mar 15, 2000	Supplement 13Manufacturing	Approved	None posted
Jun 7, 1999	Supplement 12Manufacturing	Approved	None posted
Sep 30, 1998	Supplement 10Labeling	Approved	None posted
Sep 30, 1998	Supplement 11Labeling	Approved	None posted
Oct 3, 1995	Supplement 4Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 5Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 6Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 7Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 8Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 9Labeling	Approved	None posted
Oct 22, 1991	Supplement 2Labeling	Approved	None posted
Jan 8, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62635
Drugs@FDA: Overview at FDA
Company: Epic 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