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FDA ANDA · ANDA088991

BUCET

Sponsor: MALLINCKRODT

APPLICATION
ANDA088991
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-28
LATEST ACTION
1996-08-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

BUCETDiscontinued
ACETAMINOPHEN 650MG, BUTALBITAL 50MG · CAPSULE · ORAL

Approval history

1996-08-30Manufacturing (CMC) · Supplement 18AP
1994-09-29Manufacturing (CMC) · Supplement 17AP
1994-04-12Labeling · Supplement 16AP
1994-04-12Labeling · Supplement 15AP
1992-04-08Manufacturing (CMC) · Supplement 9AP
1992-03-20Labeling · Supplement 14AP
1992-02-27Manufacturing (CMC) · Supplement 8AP
1992-02-27Manufacturing (CMC) · Supplement 13AP
1989-10-05Labeling · Supplement 12AP
1989-08-18Manufacturing (CMC) · Supplement 11AP
1989-02-07Labeling · Supplement 7AP
1989-02-07Manufacturing (CMC) · Supplement 5AP
1989-02-07Manufacturing (CMC) · Supplement 3AP
1989-02-07Manufacturing (CMC) · Supplement 6AP
1989-02-07Manufacturing (CMC) · Supplement 4AP
1989-01-11Labeling · Supplement 10AP
1985-06-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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