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FDA ANDA · ANDA083186

PROPOXYPHENE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA083186
TYPE
ANDA
ORIGINAL APPROVAL
1972-12-18
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDEDiscontinued
PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 45AP
1994-12-23Manufacturing (CMC) · Supplement 44AP
1992-04-03Manufacturing (CMC) · Supplement 43AP
1992-04-03Manufacturing (CMC) · Supplement 41AP
1987-04-10Manufacturing (CMC) · Supplement 40AP
1972-12-18OriginalAP
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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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