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FDA ANDA · ANDA086162

BUTALBITAL, ASPIRIN AND CAFFEINE

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA086162
TYPE
ANDA
ORIGINAL APPROVAL
1979-06-05
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BUTALBITAL, ASPIRIN AND CAFFEINE · ReferenceDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 55 · standardAP
2024-11-04Labeling · Supplement 54 · standardAP
1999-06-24Manufacturing (CMC) · Supplement 45AP
1998-10-01Manufacturing (CMC) · Supplement 44AP
1997-07-17Manufacturing (CMC) · Supplement 42AP
1997-07-17Manufacturing (CMC) · Supplement 40AP
1997-07-17Manufacturing (CMC) · Supplement 39AP
1997-07-17Manufacturing (CMC) · Supplement 43AP
1997-07-17Manufacturing (CMC) · Supplement 41AP
1996-10-23Manufacturing (CMC) · Supplement 36AP
1996-08-12Manufacturing (CMC) · Supplement 38AP
1996-02-29Manufacturing (CMC) · Supplement 37AP
1992-06-30Labeling · Supplement 32AP
1991-01-31Manufacturing (CMC) · Supplement 31AP
1989-05-24Labeling · Supplement 28AP
1989-05-24Manufacturing (CMC) · Supplement 27AP
1989-04-10Bioequivalence · Supplement 29AP
1989-02-02Labeling · Supplement 26AP
1988-11-17Labeling · Supplement 24AP
1988-11-17Manufacturing (CMC) · Supplement 22AP
1988-11-17Manufacturing (CMC) · Supplement 25AP
1988-11-17Manufacturing (CMC) · Supplement 23AP
1988-11-17Manufacturing (CMC) · Supplement 21AP
1988-08-23Manufacturing (CMC) · Supplement 18AP
1988-08-23Manufacturing (CMC) · Supplement 20AP
1988-08-23Manufacturing (CMC) · Supplement 17AP
1984-02-16Manufacturing (CMC) · Supplement 12AP
1982-10-18Manufacturing (CMC) · Supplement 9AP
1979-06-05OriginalAP
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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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