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FDA ANDA · ANDA075351
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Sponsor: NOVITIUM PHARMA
APPLICATION
ANDA075351
TYPE
ANDA
ORIGINAL APPROVAL
1999-03-05
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL
Approval history
2026-06-18REMS · Supplement 12AP
2025-12-22Labeling · Supplement 11 · standardAP
2025-04-30REMS · Supplement 9AP
2024-11-21Labeling · Supplement 10 · standardAP
2024-10-23Labeling · Supplement 8 · standardAP
2023-12-15Labeling · Supplement 7 · standardAP
2023-12-04Labeling · Supplement 6 · standardAP
2023-12-04Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 5 · standardAP
2002-07-18Manufacturing (CMC) · Supplement 2AP
2001-06-07Manufacturing (CMC) · Supplement 1AP
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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