← FDA DRUG APPROVALS
FDA ANDA · ANDA075929
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Sponsor: PHARMOBEDIENT
APPLICATION
ANDA075929
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-22
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL
Approval history
2026-06-18REMS · Supplement 32AP
2024-10-31REMS · Supplement 31AP
2018-09-18REMS · Supplement 24 · standardAP
2014-08-04Labeling · Supplement 13 · standardAP
2013-08-15Labeling · Supplement 11 · standardAP
2011-11-29Labeling · Supplement 8AP
2008-09-19Labeling · Supplement 5AP
2008-02-15Labeling · Supplement 4AP
2007-10-25Labeling · Supplement 3AP
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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