APPLICATION
ANDA089988
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-26
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTAPAPDiscontinued
ACETAMINOPHEN 650MG, BUTALBITAL 50MG · TABLET · ORAL
Approval history
2002-08-13Manufacturing (CMC) · Supplement 8AP
2001-03-28Manufacturing (CMC) · Supplement 7AP
2000-07-24Labeling · Supplement 4AP
1998-09-25Manufacturing (CMC) · Supplement 6AP
1998-07-31Manufacturing (CMC) · Supplement 5AP
1995-02-08Manufacturing (CMC) · Supplement 2AP
1994-02-08Labeling · Supplement 1AP
1992-10-26OriginalAP
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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