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FDA NDA · NDA021319

AVODART

Sponsor: WAYLIS THERAP

APPLICATION
NDA021319
TYPE
NDA
ORIGINAL APPROVAL
2001-11-20
LATEST ACTION
2020-01-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

AVODART · ReferencePrescription
DUTASTERIDE 0.5MG · CAPSULE · ORAL

Approval history

2020-01-30Labeling · Supplement 32 · standard — Label ↗AP
2013-09-10Manufacturing (CMC) · Supplement 30 · standardAP
2013-04-30Labeling · Supplement 28 · unknown — Label ↗AP
2013-04-30Labeling · Supplement 29 · standard — Label ↗AP
2012-06-27Labeling · Supplement 27 · unknown — Label ↗AP
2011-06-09Labeling · Supplement 25 · unknown — Label ↗AP
2011-06-09Efficacy · Supplement 23 · standard — Letter ↗AP
2010-09-09Labeling · Supplement 22 · unknown — Label ↗AP
2010-06-15Labeling · Supplement 18 · standard — Letter ↗AP
2008-06-19Efficacy · Supplement 14 · unknown — Letter ↗AP
2008-03-31Labeling · Supplement 15 · standard — Letter ↗AP
2005-12-23Labeling · Supplement 9 · standard — Letter ↗AP
2004-09-14Efficacy · Supplement 8 · unknown — Label ↗AP
2004-08-05Labeling · Supplement 7 · standard — Letter ↗AP
2004-03-12Labeling · Supplement 5 · standard — Letter ↗AP
2002-12-31Manufacturing (CMC) · Supplement 4 · standardAP
2002-10-09Manufacturing (CMC) · Supplement 2 · standardAP
2002-10-09Efficacy · Supplement 1 · standard — Letter ↗AP
2001-11-20Type 1 - New Molecular Entity · Original · standard — Label ↗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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