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FDA NDA · NDA050674

VANTIN

Sponsor: PFIZER

APPLICATION
NDA050674
TYPE
NDA
ORIGINAL APPROVAL
1992-08-07
LATEST ACTION
2013-06-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VANTIN · ReferenceDiscontinued
CEFPODOXIME PROXETIL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
VANTIN · ReferenceDiscontinued
CEFPODOXIME PROXETIL EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2013-06-21Labeling · Supplement 15 · standard — Letter ↗AP
2007-06-05Labeling · Supplement 14 · standard — Label ↗AP
2004-06-02Labeling · Supplement 13 · standard — Label ↗AP
1998-11-20Efficacy · Supplement 12 · standard — Letter ↗AP
1996-05-07Efficacy · Supplement 5 · unknownAP
1996-03-14Efficacy · Supplement 7 · standardAP
1996-03-14Labeling · Supplement 8 · standardAP
1996-02-07Labeling · Supplement 10 · standardAP
1995-09-28Labeling · Supplement 9 · standardAP
1994-07-06Labeling · Supplement 4 · standardAP
1993-11-02Labeling · Supplement 3 · standardAP
1993-05-28Efficacy · Supplement 1AP
1993-04-08Labeling · Supplement 2 · standardAP
1992-08-07Type 1 - New Molecular Entity · 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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