APPLICATION
ANDA078149
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-13
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BUTALBITAL, ASPIRIN AND CAFFEINEPrescription
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 5 · standardAP
2008-03-20Manufacturing (CMC) · Supplement 2AP
2008-03-20Manufacturing (CMC) · Supplement 3AP
2007-06-13OriginalAP
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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