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FDA NDA · NDA050679

MAXIPIME

Sponsor: HOSPIRA INC

APPLICATION
NDA050679
TYPE
NDA
ORIGINAL APPROVAL
1996-01-18
LATEST ACTION
2021-08-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2021-08-11Labeling · Supplement 46 · standard — Label ↗AP
2017-05-03Labeling · Supplement 42 · standard — Label ↗AP
2016-06-22Manufacturing (CMC) · Supplement 41 · standardAP
2016-03-04Manufacturing (CMC) · Supplement 39 · standardAP
2016-03-01Labeling · Supplement 40 · standard — Label ↗AP
2014-06-12Manufacturing (CMC) · Supplement 38 · standardAP
2014-05-01Labeling · Supplement 31 · standard — Label ↗AP
2013-03-15Labeling · Supplement 34 · unknown — Label ↗AP
2012-09-06Labeling · Supplement 36 · standard — Letter ↗AP
2009-09-30Labeling · Supplement 32 · standard — Label ↗AP
2007-09-14Labeling · Supplement 28 · standard — Label ↗AP
2007-09-14Labeling · Supplement 24 · standard — Letter ↗AP
2004-06-09Labeling · Supplement 23 · standard — Letter ↗AP
2003-03-17Efficacy · Supplement 21 · standard — Label ↗AP
2002-08-21Labeling · Supplement 9 · standard — Letter ↗AP
2002-08-21Labeling · Supplement 18 · standard — Letter ↗AP
2002-08-21Labeling · Supplement 14 · standard — Letter ↗AP
2002-03-15Manufacturing (CMC) · Supplement 20 · standardAP
2001-06-20Manufacturing (CMC) · Supplement 19 · standardAP
2001-04-02Manufacturing (CMC) · Supplement 17 · standardAP
2000-09-20Labeling · Supplement 13 · standardAP
2000-06-26Labeling · Supplement 15 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 16 · standardAP
1999-02-08Labeling · Supplement 5 · standardAP
1999-01-27Labeling · Supplement 7 · standard — Label ↗AP
1998-11-24Manufacturing (CMC) · Supplement 12 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 11 · standardAP
1998-01-30Efficacy · Supplement 8 · unknownAP
1998-01-30Manufacturing (CMC) · Supplement 10 · standardAP
1997-10-20Manufacturing (CMC) · Supplement 4 · standardAP
1997-05-16Efficacy · Supplement 2 · standard — Review ↗AP
1996-12-23Manufacturing (CMC) · Supplement 3 · standardAP
1996-03-13Manufacturing (CMC) · Supplement 1 · standardAP
1996-01-18Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗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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