APPLICATION
ANDA204195
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-22
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ASPIRIN AND CAFFEINEDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 2 · standardAP
2016-09-22UNKNOWN · OriginalAP
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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