← FDA DRUG APPROVALS

FDA NDA · NDA050749

OMNICEF

Sponsor: ABBVIE

APPLICATION
NDA050749
TYPE
NDA
ORIGINAL APPROVAL
1997-12-04
LATEST ACTION
2015-11-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

OMNICEF · ReferenceDiscontinued
CEFDINIR 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
OMNICEF · ReferenceDiscontinued
CEFDINIR 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL

Approval history

2015-11-18Labeling · Supplement 23 · standard — Label ↗AP
2008-12-15Labeling · Supplement 21 · standard — Label ↗AP
2007-09-14Labeling · Supplement 18 · standard — Label ↗AP
2007-06-15Labeling · Supplement 17 · standard — Letter ↗AP
2005-07-19Labeling · Supplement 13 · standard — Label ↗AP
2004-09-02Labeling · Supplement 9 · standard — Letter ↗AP
2004-07-29Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2001-06-18Manufacturing (CMC) · Supplement 6 · standardAP
1999-07-14Efficacy · Supplement 2 · standard — Label ↗AP
1999-07-13Labeling · Supplement 4 · standardAP
1998-04-22Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-04Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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