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FDA ANDA · ANDA085732

PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE

Sponsor: WATSON LABS

APPLICATION
ANDA085732
TYPE
ANDA
ORIGINAL APPROVAL
1978-08-21
LATEST ACTION
1989-03-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINEDiscontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

1989-03-09Labeling · Supplement 18AP
1978-08-21OriginalAP
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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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