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FDA ANDA · ANDA083089

PROPOXYPHENE HYDROCHLORIDE

Sponsor: ROXANE

APPLICATION
ANDA083089
TYPE
ANDA
ORIGINAL APPROVAL
1973-08-13
LATEST ACTION
1991-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDEDiscontinued
PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL
PROPOXYPHENE HYDROCHLORIDEDiscontinued
PROPOXYPHENE HYDROCHLORIDE 32MG · CAPSULE · ORAL

Approval history

1991-06-18Labeling · Supplement 23AP
1973-08-13OriginalAP
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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