Gentamicin Sulfate

ANDA 65121, held by Padagis US. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 65121 (Gentamicin Sulfate), held by Padagis US, was first approved by FDA on Jan 30, 2004, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 30, 2004
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 30, 2004	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 2 submissions, including labeling and manufacturing supplements


Jul 11, 2014	Supplement 2Manufacturing	Approved	None posted
Jan 30, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 65121
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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