← FDA DRUG APPROVALS

FDA ANDA · ANDA061490

OXACILLIN SODIUM

Sponsor: SANDOZ

APPLICATION
ANDA061490
TYPE
ANDA
ORIGINAL APPROVAL
1971-04-08
LATEST ACTION
2016-04-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2016-04-11Labeling · Supplement 32AP
2016-04-11Labeling · Supplement 39 · standardAP
2016-04-11Manufacturing (CMC) · Supplement 37AP
2014-12-02Labeling · Supplement 33AP
2012-03-27Labeling · Supplement 35AP
2004-10-04Labeling · Supplement 25AP
2004-10-04Labeling · Supplement 23AP
2004-10-04Labeling · Supplement 24AP
1991-05-09Labeling · Supplement 20AP
1989-12-22Manufacturing (CMC) · Supplement 19AP
1971-04-08OriginalAP
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 →