APPLICATION
NDA017534
TYPE
NDA
ORIGINAL APPROVAL
1976-05-04
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued
Products
FIORINAL · ReferenceDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FIORINAL · ReferenceDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2014-10-16Manufacturing (CMC) · Supplement 73 · standardAP
2014-07-21Manufacturing (CMC) · Supplement 72 · standardAP
2013-06-03Manufacturing (CMC) · Supplement 71 · standardAP
2002-04-26Manufacturing (CMC) · Supplement 56 · standardAP
2001-06-28Manufacturing (CMC) · Supplement 55 · standardAP
2001-05-30Manufacturing (CMC) · Supplement 54 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 51 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 50 · standardAP
1999-03-01Manufacturing (CMC) · Supplement 49 · standardAP
1997-02-27Labeling · Supplement 40AP
1996-01-18Labeling · Supplement 45 · standardAP
1995-11-24Manufacturing (CMC) · Supplement 48 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 46 · standardAP
1995-04-05Manufacturing (CMC) · Supplement 43 · standardAP
1994-05-18Manufacturing (CMC) · Supplement 29 · standardAP
1994-04-05Manufacturing (CMC) · Supplement 44 · standardAP
1993-03-19Manufacturing (CMC) · Supplement 41 · standardAP
1993-03-19Manufacturing (CMC) · Supplement 42 · standardAP
1992-08-14Manufacturing (CMC) · Supplement 39 · standardAP
1992-07-27Labeling · Supplement 38AP
1992-07-27Manufacturing (CMC) · Supplement 36 · standardAP
1992-07-27Manufacturing (CMC) · Supplement 34 · standardAP
1992-07-22Manufacturing (CMC) · Supplement 37 · standardAP
1992-07-22Manufacturing (CMC) · Supplement 33 · standardAP
1992-07-22Manufacturing (CMC) · Supplement 32 · standardAP
1989-04-07Manufacturing (CMC) · Supplement 31 · standardAP
1988-11-17Manufacturing (CMC) · Supplement 30 · standardAP
1988-03-31Manufacturing (CMC) · Supplement 28 · standardAP
1986-04-16Manufacturing (CMC) · Supplement 22 · standardAP
1985-02-15Manufacturing (CMC) · Supplement 25 · standardAP
1985-02-15Manufacturing (CMC) · Supplement 24 · standardAP
1984-12-11Manufacturing (CMC) · Supplement 23 · standardAP
1981-08-10Manufacturing (CMC) · Supplement 20 · standardAP
1981-08-10Manufacturing (CMC) · Supplement 21 · standardAP
1981-01-29Manufacturing (CMC) · Supplement 19 · standardAP
1980-12-18Manufacturing (CMC) · Supplement 18 · standardAP
1979-12-21Manufacturing (CMC) · Supplement 15 · standardAP
1979-09-14Manufacturing (CMC) · Supplement 14 · standardAP
1979-05-31Manufacturing (CMC) · Supplement 12 · standardAP
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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