← FDA DRUG APPROVALS
FDA ANDA · ANDA204649
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Sponsor: QUAGEN
APPLICATION
ANDA204649
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-08
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 8AP
2024-10-31REMS · Supplement 4AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.