APPLICATION
ANDA207313
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-27
LATEST ACTION
2017-12-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BUTALBITAL AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, BUTALBITAL 50MG · CAPSULE · ORAL
Approval history
2017-12-27UNKNOWN · 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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