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FDA ANDA · ANDA040341

PERCOCET

Sponsor: VINTAGE PHARMS LLC

APPLICATION
ANDA040341
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-26
LATEST ACTION
2006-11-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERCOCETDiscontinued
ACETAMINOPHEN 650MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
PERCOCETDiscontinued
ACETAMINOPHEN 500MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL

Approval history

2006-11-30Labeling · Supplement 13 — Label ↗AP
2002-07-31Manufacturing (CMC) · Supplement 9AP
2001-11-21Manufacturing (CMC) · Supplement 8AP
2001-10-18Manufacturing (CMC) · Supplement 7AP
2000-05-18Manufacturing (CMC) · Supplement 5AP
2000-05-18Manufacturing (CMC) · Supplement 1AP
2000-05-18Manufacturing (CMC) · Supplement 6AP
2000-05-18Manufacturing (CMC) · Supplement 2AP
2000-01-11Labeling · Supplement 4AP
1999-11-02Labeling · Supplement 3AP
1999-07-26Original — Letter ↗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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