APPLICATION
ANDA214287
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-18
LATEST ACTION
2024-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2024-01-18UNKNOWN · Original · standardAP
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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