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FDA ANDA · ANDA076560
FIORICET WITH CODEINE
butalbital, acetaminophen, caffeine, and codeine phosphate
Sponsor: LGM PHARMA
APPLICATION
ANDA076560
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-10
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL
Approval history
2026-06-18REMS · Supplement 13AP
2024-10-31REMS · Supplement 11AP
2018-09-18REMS · Supplement 8AP
2016-03-25Labeling · Supplement 6 · standardAP
2012-07-19Labeling · Supplement 3AP
2012-07-19Labeling · Supplement 4AP
2011-10-21Labeling · Supplement 5AP
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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