← FDA DRUG APPROVALS

FDA NDA · NDA050596

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: STERIMAX

APPLICATION
NDA050596
TYPE
NDA
ORIGINAL APPROVAL
1985-05-20
LATEST ACTION
2015-03-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CEFOTAXIME SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CEFOTAXIME SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CEFOTAXIME SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CEFOTAXIME SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

2015-03-23Labeling · Supplement 42 · standard — Label ↗AP
2014-04-21Manufacturing (CMC) · Supplement 41 · standardAP
2014-02-21Labeling · Supplement 40 · standard — Label ↗AP
2013-05-03Manufacturing (CMC) · Supplement 39 · standardAP
2011-09-09Labeling · Supplement 37 · standard — Label ↗AP
2009-05-27Labeling · Supplement 36 · standard — Letter ↗AP
2008-02-21Labeling · Supplement 35 · standard — Letter ↗AP
2004-09-02Labeling · Supplement 31 · standardAP
2004-06-23Labeling · Supplement 30 · standard — Letter ↗AP
2002-01-18Labeling · Supplement 23 · standard — Letter ↗AP
2001-09-06Manufacturing (CMC) · Supplement 28 · standardAP
2001-07-27Manufacturing (CMC) · Supplement 27 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 26 · standardAP
2001-04-10Manufacturing (CMC) · Supplement 25 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 24 · standardAP
1997-04-24Labeling · Supplement 22 · standardAP
1996-12-23Labeling · Supplement 20 · standardAP
1996-09-24Labeling · Supplement 10AP
1996-04-30Labeling · Supplement 18 · standardAP
1994-11-22Labeling · Supplement 13 · standardAP
1994-09-14Labeling · Supplement 16 · standardAP
1994-09-02Labeling · Supplement 17 · standardAP
1994-06-16Manufacturing (CMC) · Supplement 14 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 12 · standardAP
1992-08-10Manufacturing (CMC) · Supplement 9 · standardAP
1992-03-05Manufacturing (CMC) · Supplement 7 · standardAP
1989-08-07Manufacturing (CMC) · Supplement 8 · standardAP
1985-09-23Labeling · Supplement 2AP
1985-07-23Labeling · Supplement 3AP
1985-06-13Labeling · Supplement 1AP
1985-05-20Type 3 - New Dosage Form · Original · standardAP
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 →