APPLICATION
ANDA087550
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-19
LATEST ACTION
1993-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTALBITAL AND ACETAMINOPHEN · ReferenceDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG · TABLET · ORAL
Approval history
1993-11-12Labeling · Supplement 3AP
1992-02-26Labeling · Supplement 2AP
1992-01-08Labeling · Supplement 1AP
1984-10-19OriginalAP
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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