← FDA DRUG APPROVALS
FDA ANDA · ANDA075231
ASCOMP WITH CODEINE
butalbital, aspirin, cafeine, and codeine phosphate
Sponsor: LGM PHARMA
APPLICATION
ANDA075231
TYPE
ANDA
ORIGINAL APPROVAL
2001-11-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEPrescription
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL
Approval history
2026-06-18REMS · Supplement 16AP
2025-12-22Labeling · Supplement 14 · standardAP
2025-05-09Labeling · Supplement 13 · standardAP
2024-10-31REMS · Supplement 12AP
2024-02-12Labeling · Supplement 10 · standardAP
2024-02-12Labeling · Supplement 9 · standardAP
2024-02-12Labeling · Supplement 7 · standardAP
2024-02-12Labeling · Supplement 11 · standardAP
2018-09-18REMS · Supplement 8AP
2015-11-20Labeling · Supplement 6 · standardAP
2002-12-17Manufacturing (CMC) · Supplement 1AP
2002-12-17Labeling · Supplement 2AP
2002-08-20Manufacturing (CMC) · 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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