APPLICATION
ANDA209587
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-31
LATEST ACTION
2018-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2018-12-28Manufacturing (CMC) · Supplement 1 · unknownAP
2018-10-31UNKNOWN · 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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