← FDA DRUG APPROVALS

FDA ANDA · ANDA204733

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: AUROLIFE PHARMA LLC

APPLICATION
ANDA204733
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-26
LATEST ACTION
2025-08-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-08-04Labeling · Supplement 1 · standardAP
2018-09-26UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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