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FDA ANDA · ANDA214088

BUTALBITAL AND ACETAMINOPHEN

Sponsor: SENORES PHARMS

APPLICATION
ANDA214088
TYPE
ANDA
ORIGINAL APPROVAL
2022-04-07
LATEST ACTION
2022-04-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BUTALBITAL AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 50MG · TABLET · ORAL
BUTALBITAL AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, BUTALBITAL 50MG · TABLET · ORAL
BUTALBITAL AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 25MG · TABLET · ORAL

Approval history

2022-04-07UNKNOWN · Original · standardAP
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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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