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FDA ANDA · ANDA090956

BUTALBITAL AND ACETAMINOPHEN

butalbital and acetaminophen tablets

Sponsor: LGM PHARMA

APPLICATION
ANDA090956
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-23
LATEST ACTION
2014-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BUTALBITAL AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, BUTALBITAL 50MG · TABLET · ORAL

Approval history

2014-04-09Labeling · Supplement 1 · standardAP
2011-08-23OriginalAP
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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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