APPLICATION
ANDA205230
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-18
LATEST ACTION
2025-01-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ASPIRIN AND CAFFEINEDiscontinued
ASPIRIN 500MG, BUTALBITAL 50MG, CAFFEINE 40MG · CAPSULE · ORAL
Approval history
2025-01-21Labeling · Supplement 1 · standardAP
2021-10-18UNKNOWN · Original · standardAP
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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