← FDA DRUG APPROVALS

FDA NDA · NDA050587

PRIMAXIN IV

imipenem and cilastatin sodium

Sponsor: MERCK

APPLICATION
NDA050587
TYPE
NDA
ORIGINAL APPROVAL
1985-11-26
LATEST ACTION
2022-01-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued, Prescription

Products

PRIMAXIN · ReferenceDiscontinued
CILASTATIN SODIUM EQ 250MG BASE/VIAL, IMIPENEM 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS
PRIMAXIN · ReferencePrescription
CILASTATIN SODIUM EQ 500MG BASE/VIAL, IMIPENEM 500MG/VIAL · POWDER · INTRAVENOUS

Approval history

2022-01-30Labeling · Supplement 83 · standard — Letter ↗AP
2018-12-12Labeling · Supplement 81 · standard — Label ↗AP
2018-08-06Manufacturing (CMC) · Supplement 80AP
2016-12-16Labeling · Supplement 74 · standard — Label ↗AP
2016-03-11Manufacturing (CMC) · Supplement 78 · priorityAP
2016-02-19Manufacturing (CMC) · Supplement 77 · priorityAP
2014-12-16Labeling · Supplement 76 · standard — Letter ↗AP
2014-08-26Manufacturing (CMC) · Supplement 75 · priorityAP
2012-04-16Labeling · Supplement 73 · standard — Label ↗AP
2009-08-26Labeling · Supplement 72 · unknown — Label ↗AP
2008-05-08Labeling · Supplement 70 · standard — Letter ↗AP
2008-03-28Labeling · Supplement 65 · standard — Label ↗AP
2006-08-04Labeling · Supplement 64 · standard — Letter ↗AP
2004-05-20Labeling · Supplement 61 · standard — Review ↗AP
2003-03-04Labeling · Supplement 58 · standard — Review ↗AP
2002-07-09Manufacturing (CMC) · Supplement 59 · priority — Review ↗AP
2002-05-28Manufacturing (CMC) · Supplement 56 · priorityAP
2001-11-30Labeling · Supplement 53 · standard — Letter ↗AP
2001-08-29Manufacturing (CMC) · Supplement 55 · priority — Review ↗AP
2001-07-23Manufacturing (CMC) · Supplement 54 · priority — Review ↗AP
2000-08-28Labeling · Supplement 52 · standard — Review ↗AP
1999-07-13Manufacturing (CMC) · Supplement 51 · priorityAP
1999-02-04Labeling · Supplement 50 · standardAP
1998-07-24Manufacturing (CMC) · Supplement 49 · priorityAP
1998-04-08Efficacy · Supplement 48 · standard — Label ↗AP
1997-06-30Labeling · Supplement 47 · standardAP
1997-01-09Labeling · Supplement 45 · standard — Review ↗AP
1996-09-19Manufacturing (CMC) · Supplement 46 · priority — Review ↗AP
1996-09-12Labeling · Supplement 39 — Review ↗AP
1995-03-21Labeling · Supplement 41 · standard — Review ↗AP
1995-03-10Manufacturing (CMC) · Supplement 44 · priorityAP
1994-09-27Manufacturing (CMC) · Supplement 42 · priorityAP
1994-06-24Labeling · Supplement 38AP
1994-03-07Labeling · Supplement 26AP
1993-11-19Labeling · Supplement 40 · standardAP
1993-11-04Labeling · Supplement 33AP
1992-11-23Labeling · Supplement 36AP
1992-07-17Manufacturing (CMC) · Supplement 37 · priorityAP
1992-01-14Manufacturing (CMC) · Supplement 35 · priorityAP
1991-08-26Manufacturing (CMC) · Supplement 28 · 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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