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FDA ANDA · ANDA070116

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: MUTUAL PHARM

APPLICATION
ANDA070116
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-01
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1998-12-01Manufacturing (CMC) · Supplement 22AP
1995-10-06Manufacturing (CMC) · Supplement 17AP
1994-12-23Manufacturing (CMC) · Supplement 21AP
1992-04-03Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 20AP
1989-08-03Labeling · Supplement 16AP
1989-03-24Labeling · Supplement 15AP
1988-09-08Manufacturing (CMC) · Supplement 14AP
1985-12-10Manufacturing (CMC) · Supplement 2AP
1985-12-10Manufacturing (CMC) · Supplement 1AP
1985-10-22Manufacturing (CMC) · Supplement 5AP
1985-10-01OriginalAP
VIEW ON DRUGS@FDA ↗

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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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