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FDA ANDA · ANDA070910

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA070910
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-02
LATEST ACTION
2001-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2001-11-02Manufacturing (CMC) · Supplement 30AP
2001-09-24Manufacturing (CMC) · Supplement 28AP
2001-09-24Manufacturing (CMC) · Supplement 29AP
2001-06-15Manufacturing (CMC) · Supplement 27AP
1998-03-25Manufacturing (CMC) · Supplement 25AP
1997-08-20Manufacturing (CMC) · Supplement 22AP
1996-01-18Manufacturing (CMC) · Supplement 26AP
1994-08-19Manufacturing (CMC) · Supplement 24AP
1993-09-14Manufacturing (CMC) · Supplement 23AP
1991-01-11Labeling · Supplement 21AP
1990-06-14Manufacturing (CMC) · Supplement 17AP
1990-06-14Manufacturing (CMC) · Supplement 18AP
1990-06-14Manufacturing (CMC) · Supplement 19AP
1989-08-23Labeling · Supplement 10AP
1989-06-01Bioequivalence · Supplement 14AP
1988-10-05Labeling · Supplement 11AP
1988-04-08Manufacturing (CMC) · Supplement 8AP
1988-04-08Manufacturing (CMC) · Supplement 7AP
1987-09-16Manufacturing (CMC) · Supplement 4AP
1987-04-13Manufacturing (CMC) · Supplement 2AP
1987-04-13Manufacturing (CMC) · Supplement 1AP
1987-01-02OriginalAP
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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