← FDA DRUG APPROVALS

FDA ANDA · ANDA089025

PROPOXYPHENE COMPOUND 65

Sponsor: TEVA

APPLICATION
ANDA089025
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-29
LATEST ACTION
2002-11-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE COMPOUND 65Discontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

2002-11-14Manufacturing (CMC) · Supplement 42AP
2001-12-20Manufacturing (CMC) · Supplement 41AP
2001-12-20Manufacturing (CMC) · Supplement 40AP
2000-07-07Manufacturing (CMC) · Supplement 39AP
1998-08-26Manufacturing (CMC) · Supplement 38AP
1998-03-09Manufacturing (CMC) · Supplement 37AP
1998-03-06Labeling · Supplement 36AP
1997-06-02Manufacturing (CMC) · Supplement 35AP
1997-03-19Manufacturing (CMC) · Supplement 34AP
1996-11-04Manufacturing (CMC) · Supplement 33AP
1996-08-16Labeling · Supplement 32AP
1996-01-25Manufacturing (CMC) · Supplement 30AP
1996-01-25Manufacturing (CMC) · Supplement 29AP
1996-01-25Manufacturing (CMC) · Supplement 31AP
1995-03-02Manufacturing (CMC) · Supplement 28AP
1994-11-03Manufacturing (CMC) · Supplement 7AP
1994-03-15Manufacturing (CMC) · Supplement 20AP
1994-01-26Manufacturing (CMC) · Supplement 24AP
1994-01-26Manufacturing (CMC) · Supplement 22AP
1994-01-26Manufacturing (CMC) · Supplement 27AP
1994-01-26Manufacturing (CMC) · Supplement 25AP
1994-01-26Manufacturing (CMC) · Supplement 23AP
1994-01-26Manufacturing (CMC) · Supplement 26AP
1993-07-30Manufacturing (CMC) · Supplement 14AP
1993-07-30Manufacturing (CMC) · Supplement 21AP
1993-05-25Manufacturing (CMC) · Supplement 18AP
1993-05-25Manufacturing (CMC) · Supplement 12AP
1993-05-25Manufacturing (CMC) · Supplement 19AP
1993-05-25Manufacturing (CMC) · Supplement 17AP
1993-05-25Manufacturing (CMC) · Supplement 13AP
1993-04-01Manufacturing (CMC) · Supplement 16AP
1993-04-01Manufacturing (CMC) · Supplement 15AP
1993-04-01Manufacturing (CMC) · Supplement 11AP
1990-10-11Bioequivalence · Supplement 10AP
1989-07-11Labeling · Supplement 6AP
1989-04-17Manufacturing (CMC) · Supplement 3AP
1989-04-17Manufacturing (CMC) · Supplement 4AP
1989-04-17Manufacturing (CMC) · Supplement 2AP
1989-02-08Labeling · Supplement 5AP
1985-03-29OriginalAP
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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