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FDA NDA · NDA050547

CLAFORAN

Sponsor: STERIMAX

APPLICATION
NDA050547
TYPE
NDA
ORIGINAL APPROVAL
1981-03-11
LATEST ACTION
2015-03-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CLAFORAN · ReferenceDiscontinued
CEFOTAXIME SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CLAFORAN · ReferenceDiscontinued
CEFOTAXIME SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CLAFORAN · ReferenceDiscontinued
CEFOTAXIME SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CLAFORAN · ReferenceDiscontinued
CEFOTAXIME SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2015-03-23Labeling · Supplement 71 · standard — Label ↗AP
2014-02-21Labeling · Supplement 70 · standard — Label ↗AP
2011-09-09Labeling · Supplement 68 · standard — Letter ↗AP
2009-05-27Labeling · Supplement 67 · standard — Letter ↗AP
2008-02-21Labeling · Supplement 66 · standard — Letter ↗AP
2004-09-02Labeling · Supplement 61 · standard — Letter ↗AP
2004-06-23Labeling · Supplement 60 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 57 · priorityAP
2002-01-18Labeling · Supplement 47 · standard — Letter ↗AP
2001-09-06Manufacturing (CMC) · Supplement 56 · priorityAP
2001-07-27Manufacturing (CMC) · Supplement 55 · priorityAP
2001-04-12Manufacturing (CMC) · Supplement 54 · priorityAP
2001-04-10Manufacturing (CMC) · Supplement 53 · priorityAP
2000-02-18Manufacturing (CMC) · Supplement 52 · priorityAP
1998-06-26Manufacturing (CMC) · Supplement 50 · priorityAP
1998-06-16Manufacturing (CMC) · Supplement 51 · priorityAP
1998-03-16Manufacturing (CMC) · Supplement 48 · priorityAP
1997-10-28Manufacturing (CMC) · Supplement 49 · priorityAP
1997-04-24Labeling · Supplement 45 · standardAP
1996-12-23Labeling · Supplement 44 · standardAP
1996-09-27Efficacy · Supplement 42 · standardAP
1996-09-24Labeling · Supplement 15AP
1996-04-30Labeling · Supplement 38 · standardAP
1995-08-25Manufacturing (CMC) · Supplement 40 · priorityAP
1995-08-17Manufacturing (CMC) · Supplement 20 · priorityAP
1994-11-22Labeling · Supplement 21 · standardAP
1994-09-14Labeling · Supplement 24 · standardAP
1994-09-02Labeling · Supplement 25 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 18 · priorityAP
1993-11-12Manufacturing (CMC) · Supplement 23 · priorityAP
1993-10-20Manufacturing (CMC) · Supplement 26 · priorityAP
1993-01-19Manufacturing (CMC) · Supplement 22 · priorityAP
1992-06-30Manufacturing (CMC) · Supplement 19 · priorityAP
1989-08-07Labeling · Supplement 14AP
1988-06-20Manufacturing (CMC) · Supplement 13 · priorityAP
1987-07-14Labeling · Supplement 11AP
1985-10-25Manufacturing (CMC) · Supplement 10 · priorityAP
1985-09-16Manufacturing (CMC) · Supplement 8 · priorityAP
1985-06-24Manufacturing (CMC) · Supplement 9 · priorityAP
1984-12-14Manufacturing (CMC) · Supplement 7 · priorityAP
VIEW ON DRUGS@FDA ↗

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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.

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