Gentamicin Sulfate

ANDA 62413, held by Abbott. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62413 (Gentamicin Sulfate), held by Abbott, was first approved by FDA on Aug 11, 1983, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 11, 1983
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
Aug 11, 1983	Original application	Approved	None posted

Products

10 strengths and forms


Gentamicin SulfateEQ 1.2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 1.4MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 1.6MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 1.8MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 60MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 70MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 80MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 90MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin SulfateEQ 100MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 14, 1993	Supplement 6Labeling	Approved	None posted
Aug 11, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62413
Drugs@FDA: Overview at FDA
Company: Abbott

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