← FDA DRUG APPROVALS

FDA NDA · NDA021378

COMBUNOX

Sponsor: FOREST LABS

APPLICATION
NDA021378
TYPE
NDA
ORIGINAL APPROVAL
2004-11-26
LATEST ACTION
2010-09-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

COMBUNOX · ReferenceDiscontinued
IBUPROFEN 400MG, OXYCODONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2010-09-02Labeling · Supplement 6 · standard — Label ↗AP
2007-06-20Labeling · Supplement 5 · standard — Label ↗AP
2006-03-02Labeling · Supplement 2 · standard — Label ↗AP
2004-11-26Type 4 - New Combination · Original · standard — Label ↗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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