Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

ANDA 62414, held by Hospira. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62414 (Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container), held by Hospira, was first approved by FDA on Aug 15, 1983, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 15, 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
Aug 15, 1983	Original application	Approved	None posted

Products

10 strengths and forms


Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.4MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.6MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.8MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 60MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 70MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 80MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 90MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 100MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Feb 10, 2023	Supplement 58Labeling · Standard review	Approved	None posted
Jun 23, 2016	Supplement 54Labeling · Standard review	Approved	None posted
Apr 19, 2004	Supplement 32Labeling	Approved	None posted
Nov 1, 2002	Supplement 31Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 28Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 30Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 29Manufacturing	Approved	None posted
Jun 2, 1997	Supplement 26Manufacturing	Approved	None posted
Apr 8, 1997	Supplement 24Manufacturing	Approved	None posted
Jul 3, 1996	Supplement 21Manufacturing	Approved	None posted
Mar 12, 1996	Supplement 23Manufacturing	Approved	None posted
Apr 25, 1994	Supplement 19Labeling	Approved	None posted
Oct 4, 1993	Supplement 18Manufacturing	Approved	None posted
Jul 28, 1993	Supplement 17Labeling	Approved	None posted
Mar 10, 1992	Supplement 16Manufacturing	Approved	None posted
Jan 6, 1992	Supplement 13Manufacturing	Approved	None posted
Jan 18, 1991	Supplement 15Manufacturing	Approved	None posted
Aug 2, 1990	Supplement 14Manufacturing	Approved	None posted
Mar 22, 1990	Supplement 12Manufacturing	Approved	None posted
Aug 15, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62414
Drugs@FDA: Overview at FDA
Company: Hospira

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