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FDA ANDA · ANDA070115

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: MUTUAL PHARM

APPLICATION
ANDA070115
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-12
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1998-12-01Manufacturing (CMC) · Supplement 24AP
1994-12-23Manufacturing (CMC) · Supplement 23AP
1992-04-03Manufacturing (CMC) · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 20AP
1991-05-01Manufacturing (CMC) · Supplement 18AP
1990-05-07Bioequivalence · Supplement 19AP
1989-07-12Labeling · Supplement 17AP
1989-02-28Labeling · Supplement 16AP
1987-05-21Manufacturing (CMC) · Supplement 7AP
1987-03-27Manufacturing (CMC) · Supplement 10AP
1985-12-30Manufacturing (CMC) · Supplement 3AP
1985-12-30Manufacturing (CMC) · Supplement 2AP
1985-12-11Manufacturing (CMC) · Supplement 6AP
1985-12-11Manufacturing (CMC) · Supplement 4AP
1985-07-18Manufacturing (CMC) · Supplement 1AP
1985-06-12OriginalAP
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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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