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FDA ANDA · ANDA211543

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: NESHER PHARMS

APPLICATION
ANDA211543
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-17
LATEST ACTION
2020-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL

Approval history

2020-07-17UNKNOWN · Original · standardAP
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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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