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FDA ANDA · ANDA213115

BUTALBITAL AND ACETAMINOPHEN

Sponsor: GRANULES

APPLICATION
ANDA213115
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-22
LATEST ACTION
2019-11-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

BUTALBITAL AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, BUTALBITAL 50MG · CAPSULE · ORAL

Approval history

2019-11-22UNKNOWN · Original · standardLetterAP
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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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