APPLICATION
ANDA089987
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-26
LATEST ACTION
2013-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUTAPAPPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 50MG · TABLET · ORAL
Approval history
2013-10-18Labeling · Supplement 15 · standardAP
2011-06-22Labeling · Supplement 14AP
2002-08-13Manufacturing (CMC) · Supplement 10AP
2001-03-28Manufacturing (CMC) · Supplement 9AP
2001-03-28Manufacturing (CMC) · Supplement 8AP
2000-07-24Labeling · Supplement 5AP
1998-09-25Manufacturing (CMC) · Supplement 7AP
1998-07-31Manufacturing (CMC) · Supplement 6AP
1996-08-13Manufacturing (CMC) · Supplement 4AP
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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