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FDA ANDA · ANDA074119

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: TEVA

APPLICATION
ANDA074119
TYPE
ANDA
ORIGINAL APPROVAL
1994-12-19
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-08-13Manufacturing (CMC) · Supplement 22AP
2002-08-13Labeling · Supplement 23AP
2002-08-13Manufacturing (CMC) · Supplement 21AP
2000-07-07Manufacturing (CMC) · Supplement 20AP
1999-10-22Labeling · Supplement 19AP
1998-03-09Manufacturing (CMC) · Supplement 18AP
1997-06-30Manufacturing (CMC) · Supplement 14AP
1997-04-01Labeling · Supplement 17AP
1997-01-29Manufacturing (CMC) · Supplement 16AP
1996-12-13Manufacturing (CMC) · Supplement 15AP
1996-08-16Manufacturing (CMC) · Supplement 13AP
1996-06-06Manufacturing (CMC) · Supplement 12AP
1996-05-06Manufacturing (CMC) · Supplement 11AP
1996-02-12Labeling · Supplement 3AP
1995-11-17Manufacturing (CMC) · Supplement 2AP
1995-10-20Manufacturing (CMC) · Supplement 1AP
1995-10-20Manufacturing (CMC) · Supplement 10AP
1995-10-03Manufacturing (CMC) · Supplement 8AP
1995-10-03Manufacturing (CMC) · Supplement 6AP
1995-10-03Manufacturing (CMC) · Supplement 4AP
1995-10-03Manufacturing (CMC) · Supplement 9AP
1995-10-03Manufacturing (CMC) · Supplement 7AP
1995-10-03Manufacturing (CMC) · Supplement 5AP
1994-12-19OriginalAP
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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