← FDA DRUG APPROVALS

FDA ANDA · ANDA062756

PRIMAXIN

Sponsor: MERCK

APPLICATION
ANDA062756
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-08
LATEST ACTION
2017-04-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PRIMAXINDiscontinued
CILASTATIN SODIUM EQ 250MG BASE/VIAL, IMIPENEM 250MG/VIAL · INJECTABLE · INJECTION
PRIMAXINDiscontinued
CILASTATIN SODIUM EQ 500MG BASE/VIAL, IMIPENEM 500MG/VIAL · INJECTABLE · INJECTION

Approval history

2017-04-02Labeling · Supplement 56 · standardAP
2017-03-17Labeling · Supplement 58 · standardAP
2013-06-28Labeling · Supplement 55AP
2012-05-08Labeling · Supplement 51AP
2011-02-28Labeling · Supplement 53AP
2010-04-23Labeling · Supplement 46AP
2006-09-19Labeling · Supplement 45AP
2004-04-16Labeling · Supplement 41AP
2004-04-16Labeling · Supplement 39AP
2002-10-17Manufacturing (CMC) · Supplement 38 — Review ↗AP
2002-08-20Labeling · Supplement 37 — Review ↗AP
2002-04-19Manufacturing (CMC) · Supplement 35 — Review ↗AP
2001-10-11Manufacturing (CMC) · Supplement 33 — Review ↗AP
2001-10-11Manufacturing (CMC) · Supplement 34 — Review ↗AP
2001-09-10Manufacturing (CMC) · Supplement 32 — Review ↗AP
2001-08-31Labeling · Supplement 31AP
2001-08-31Labeling · Supplement 24 — Review ↗AP
1999-11-29Manufacturing (CMC) · Supplement 30 — Review ↗AP
1999-01-28Labeling · Supplement 29 — Review ↗AP
1998-03-17Labeling · Supplement 28 — Review ↗AP
1997-04-30Labeling · Supplement 23 — Review ↗AP
1996-10-31Manufacturing (CMC) · Supplement 27 — Review ↗AP
1996-10-11Labeling · Supplement 26 — Review ↗AP
1996-10-11Labeling · Supplement 18 — Review ↗AP
1996-10-11Labeling · Supplement 22 — Review ↗AP
1996-05-08Manufacturing (CMC) · Supplement 25 — Review ↗AP
1995-07-12Labeling · Supplement 19 — Review ↗AP
1995-07-12Labeling · Supplement 17 — Review ↗AP
1995-07-12Labeling · Supplement 11 — Review ↗AP
1995-05-09Manufacturing (CMC) · Supplement 21 — Review ↗AP
1994-09-02Manufacturing (CMC) · Supplement 20 — Review ↗AP
1993-12-29Labeling · Supplement 8 — Review ↗AP
1993-12-29Labeling · Supplement 7 — Review ↗AP
1993-12-29Labeling · Supplement 5 — Review ↗AP
1993-12-29Labeling · Supplement 10 — Review ↗AP
1993-02-03Labeling · Supplement 14 — Review ↗AP
1992-08-31Manufacturing (CMC) · Supplement 15 — Review ↗AP
1992-02-18Manufacturing (CMC) · Supplement 13 — Review ↗AP
1992-02-18Manufacturing (CMC) · Supplement 12 — Review ↗AP
1991-09-09Manufacturing (CMC) · Supplement 6 — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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