← FDA DRUG APPROVALS

FDA ANDA · ANDA200243

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE

Sponsor: LANNETT CO INC

APPLICATION
ANDA200243
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-13
LATEST ACTION
2016-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2016-04-15Labeling · Supplement 10 · standardAP
2012-09-13Not Applicable · OriginalAP
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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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