← FDA DRUG APPROVALS

FDA ANDA · ANDA075738

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: MALLINCKRODT

APPLICATION
ANDA075738
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-02
LATEST ACTION
2002-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-12-03Labeling · Supplement 4AP
2002-12-03Manufacturing (CMC) · Supplement 2AP
2002-12-03Manufacturing (CMC) · Supplement 3AP
2002-12-03Manufacturing (CMC) · Supplement 1AP
2001-02-02Original — Letter ↗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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