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FDA ANDA · ANDA074843

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: VINTAGE PHARMS

APPLICATION
ANDA074843
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-12
LATEST ACTION
2001-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE NAPSYLATE 100MG · TABLET · ORAL
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, PROPOXYPHENE NAPSYLATE 50MG · TABLET · ORAL

Approval history

2001-02-15Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2001-02-15Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2001-02-15Labeling · Supplement 3 — Letter ↗AP
2001-02-15Manufacturing (CMC) · Supplement 1 — Letter ↗AP
1997-02-12OriginalAP
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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