Gentacidin

ANDA 62480, held by Novartis. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62480 (Gentacidin), held by Novartis, was first approved by FDA on Mar 30, 1984, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1984
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
Mar 30, 1984	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Apr 19, 2001	Supplement 9Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 7Labeling	Approved	None posted
Aug 22, 1995	Supplement 6Manufacturing	Approved	None posted
Sep 30, 1994	Supplement 3Manufacturing	Approved	None posted
Jun 10, 1994	Supplement 4Manufacturing	Approved	None posted
May 5, 1994	Supplement 5Labeling	Approved	None posted
Aug 19, 1993	Supplement 2Labeling	Approved	None posted
Mar 30, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62480
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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