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FDA NDA · NDA050630

PRIMAXIN

Sponsor: MERCK

APPLICATION
NDA050630
TYPE
NDA
ORIGINAL APPROVAL
1990-12-14
LATEST ACTION
2009-08-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

PRIMAXINDiscontinued
CILASTATIN SODIUM EQ 500MG BASE/VIAL, IMIPENEM 500MG/VIAL · POWDER · INTRAMUSCULAR
PRIMAXINDiscontinued
CILASTATIN SODIUM EQ 750MG BASE/VIAL, IMIPENEM 750MG/VIAL · POWDER · INTRAMUSCULAR

Approval history

2009-08-26Labeling · Supplement 35 · unknown — Label ↗AP
2008-05-08Labeling · Supplement 33 · standard — Letter ↗AP
2008-03-28Labeling · Supplement 28 · standard — Label ↗AP
2007-03-22Labeling · Supplement 27 · standard — Label ↗AP
2006-08-04Labeling · Supplement 26 · standard — Letter ↗AP
2004-05-20Labeling · Supplement 23 · standard — Review ↗AP
2003-03-04Labeling · Supplement 21 · standard — Review ↗AP
2002-05-28Manufacturing (CMC) · Supplement 19 · standard — Review ↗AP
2001-11-30Labeling · Supplement 17 · standard — Letter ↗AP
2001-08-29Manufacturing (CMC) · Supplement 18 · standardAP
2000-04-10Manufacturing (CMC) · Supplement 16 · standardAP
1999-02-04Labeling · Supplement 15 · standard — Review ↗AP
1997-06-30Labeling · Supplement 14 · standard — Review ↗AP
1997-01-09Labeling · Supplement 11 · standard — Review ↗AP
1996-10-02Labeling · Supplement 9 · standard — Review ↗AP
1995-04-27Manufacturing (CMC) · Supplement 12 · standardAP
1994-09-27Manufacturing (CMC) · Supplement 10 · standardAP
1994-06-24Labeling · Supplement 8AP
1993-11-04Labeling · Supplement 5AP
1993-11-04Labeling · Supplement 2AP
1992-11-23Labeling · Supplement 7AP
1992-11-23Labeling · Supplement 6AP
1991-08-26Manufacturing (CMC) · Supplement 1 · standardAP
1990-12-14Type 3 - New Dosage Form · Original · standardAP
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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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