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FDA NDA · NDA019429

FIORINAL W/CODEINE

Sponsor: ALLERGAN

APPLICATION
NDA019429
TYPE
NDA
ORIGINAL APPROVAL
1990-10-26
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FIORINAL W/CODEINE · ReferenceDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2021-04-28Labeling · Supplement 44 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 45 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 43 · standard — Label ↗AP
2018-09-18REMS · Supplement 41 — Letter ↗AP
2018-09-18Labeling · Supplement 42 · standard — Letter ↗AP
2017-08-29Labeling · Supplement 40 · standard — Label ↗AP
2016-12-16Labeling · Supplement 49 · standardAP
2016-12-16Labeling · Supplement 39 · standard — Letter ↗AP
2015-11-06Manufacturing (CMC) · Supplement 38 · standardAP
2014-11-16Manufacturing (CMC) · Supplement 37 · standardAP
2013-05-09Labeling · Supplement 35 · standard — Letter ↗AP
2008-04-08Labeling · Supplement 23 · standard — Other ↗AP
2002-08-26Labeling · Supplement 6 · standard — Letter ↗AP
2002-04-26Manufacturing (CMC) · Supplement 19 · standardAP
2001-10-04Labeling · Supplement 16 · standardAP
2001-06-28Manufacturing (CMC) · Supplement 18 · standardAP
2001-05-30Manufacturing (CMC) · Supplement 17 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 15 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 13 · standardAP
1996-07-12Manufacturing (CMC) · Supplement 11 · standardAP
1996-03-21Manufacturing (CMC) · Supplement 9 · standardAP
1995-11-20Manufacturing (CMC) · Supplement 10 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 7 · standardAP
1994-04-05Manufacturing (CMC) · Supplement 5 · standardAP
1993-04-06Manufacturing (CMC) · Supplement 3 · standardAP
1993-04-06Manufacturing (CMC) · Supplement 4 · standardAP
1993-04-06Manufacturing (CMC) · Supplement 2 · standardAP
1991-04-29Labeling · Supplement 1AP
1990-10-26Type 4 - New Combination · Original · standard — REMS ↗AP
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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