← FDA DRUG APPROVALS

FDA ANDA · ANDA062588

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor: HOSPIRA

APPLICATION
ANDA062588
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-06
LATEST ACTION
1998-12-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 80MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 60MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.8MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 100MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.4MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 90MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 70MG BASE/100ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 2MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.6MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
GENTAMICIN SULFATE EQ 1.2MG BASE/ML · INJECTABLE · INJECTION

Approval history

1998-12-01Manufacturing (CMC) · Supplement 13AP
1997-06-02Manufacturing (CMC) · Supplement 12AP
1996-07-03Manufacturing (CMC) · Supplement 9AP
1996-03-12Manufacturing (CMC) · Supplement 10AP
1995-08-07Manufacturing (CMC) · Supplement 8AP
1992-03-10Manufacturing (CMC) · Supplement 6AP
1991-04-24Manufacturing (CMC) · Supplement 7AP
1990-08-02Manufacturing (CMC) · Supplement 5AP
1986-01-06OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →