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FDA ANDA · ANDA080269

PROPOXYPHENE HYDROCHLORIDE

Sponsor: PAR PHARM

APPLICATION
ANDA080269
TYPE
ANDA
ORIGINAL APPROVAL
1971-11-30
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDEDiscontinued
PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 109AP
2002-03-12Manufacturing (CMC) · Supplement 108AP
2000-09-21Manufacturing (CMC) · Supplement 107AP
2000-09-21Manufacturing (CMC) · Supplement 106AP
2000-04-12Manufacturing (CMC) · Supplement 105AP
2000-01-28Manufacturing (CMC) · Supplement 104AP
1999-11-23Manufacturing (CMC) · Supplement 103AP
1999-08-20Manufacturing (CMC) · Supplement 102AP
1998-12-23Manufacturing (CMC) · Supplement 101AP
1998-12-09Manufacturing (CMC) · Supplement 100AP
1997-05-30Manufacturing (CMC) · Supplement 99AP
1992-10-29Manufacturing (CMC) · Supplement 98AP
1992-09-04Manufacturing (CMC) · Supplement 97AP
1992-02-26Labeling · Supplement 96AP
1987-06-11Manufacturing (CMC) · Supplement 94AP
1987-02-18Manufacturing (CMC) · Supplement 93AP
1987-02-18Manufacturing (CMC) · Supplement 92AP
1971-11-30OriginalAP
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