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FDA NDA · NDA020579

FLOMAX

Sponsor: SANOFI

APPLICATION
NDA020579
TYPE
NDA
ORIGINAL APPROVAL
1997-04-15
LATEST ACTION
2019-01-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FLOMAX · ReferenceDiscontinued
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL

Approval history

2019-01-23Labeling · Supplement 33 · standard — Label ↗AP
2016-01-21Manufacturing (CMC) · Supplement 31 · standardAP
2014-10-20Labeling · Supplement 29 · standard — Pediatric Written Request ↗AP
2014-07-20Labeling · Supplement 28 · standard — Letter ↗AP
2011-07-25Labeling · Supplement 27 · unknown — Label ↗AP
2009-12-22Efficacy · Supplement 26 · priority — Label ↗AP
2009-10-29Labeling · Supplement 25 · standard — Label ↗AP
2008-12-02Labeling · Supplement 24 · standard — Letter ↗AP
2008-04-29Labeling · Supplement 23 · standard — Letter ↗AP
2007-02-16Labeling · Supplement 21 · standard — Label ↗AP
2007-01-11Labeling · Supplement 20 · standard — Label ↗AP
2005-10-18Labeling · Supplement 17 · standardAP
2005-10-18Labeling · Supplement 16 · standard — Letter ↗AP
2001-12-17Manufacturing (CMC) · Supplement 12 · standardAP
2001-08-20Manufacturing (CMC) · Supplement 11 · standardAP
2001-06-06Manufacturing (CMC) · Supplement 10 · standardAP
2001-05-01Labeling · Supplement 7 · standardAP
2000-07-26Manufacturing (CMC) · Supplement 9 · standardAP
2000-06-30Manufacturing (CMC) · Supplement 8 · standardAP
1999-09-02Manufacturing (CMC) · Supplement 6 · standardAP
1999-02-23Manufacturing (CMC) · Supplement 5 · standardAP
1999-01-19Manufacturing (CMC) · Supplement 4 · standardAP
1998-12-08Manufacturing (CMC) · Supplement 3 · standardAP
1998-05-26Labeling · Supplement 2 · standardAP
1997-08-25Manufacturing (CMC) · Supplement 1 · standardAP
1997-04-15Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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