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FDA ANDA · ANDA083978

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Sponsor: MYLAN

APPLICATION
ANDA083978
TYPE
ANDA
ORIGINAL APPROVAL
1974-10-25
LATEST ACTION
2000-08-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE HYDROCHLORIDE 65MG · TABLET · ORAL

Approval history

2000-08-10Manufacturing (CMC) · Supplement 210AP
1998-02-25Manufacturing (CMC) · Supplement 212AP
1998-02-05Manufacturing (CMC) · Supplement 211AP
1997-03-07Manufacturing (CMC) · Supplement 209AP
1994-01-13Manufacturing (CMC) · Supplement 208AP
1991-10-31Manufacturing (CMC) · Supplement 206AP
1991-10-31Manufacturing (CMC) · Supplement 204AP
1991-10-31Labeling · Supplement 205AP
1990-01-31Manufacturing (CMC) · Supplement 203AP
1986-09-25Manufacturing (CMC) · Supplement 200AP
1984-06-28Manufacturing (CMC) · Supplement 199AP
1983-04-25Manufacturing (CMC) · Supplement 198AP
1982-06-08Manufacturing (CMC) · Supplement 152AP
1974-10-25OriginalAP
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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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