← FDA DRUG APPROVALS

FDA NDA · NDA020788

PROPECIA

finasteride

Sponsor: ORGANON

APPLICATION
NDA020788
TYPE
NDA
ORIGINAL APPROVAL
1997-12-19
LATEST ACTION
2022-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROPECIA · ReferencePrescription
FINASTERIDE 1MG · TABLET · ORAL

Approval history

2022-08-01Labeling · Supplement 30 · standard — Letter ↗AP
2021-06-15Labeling · Supplement 28 · standard — Letter ↗AP
2016-01-11Manufacturing (CMC) · Supplement 26 · standardAP
2014-01-31Labeling · Supplement 24 · standard — Label ↗AP
2012-04-11Labeling · Supplement 23 · unknown — Review ↗AP
2012-04-11Labeling · Supplement 21 · unknown — Review ↗AP
2012-04-11Labeling · Supplement 20 · unknown — Review ↗AP
2011-06-10Labeling · Supplement 16 · unknown — Letter ↗AP
2011-06-09Labeling · Supplement 22 · unknown — Letter ↗AP
2011-04-13Labeling · Supplement 18 · unknown — Review ↗AP
2011-03-11Labeling · Supplement 17 · unknown — Label ↗AP
2010-03-24Labeling · Supplement 15 · unknown — Letter ↗AP
2006-11-01Manufacturing (CMC) · Supplement 14AP
2004-10-21Labeling · Supplement 11 · standard — Letter ↗AP
2004-10-21Labeling · Supplement 2 · standard — Letter ↗AP
2004-10-21Labeling · Supplement 10 · standard — Letter ↗AP
2002-10-30Manufacturing (CMC) · Supplement 8 · standardAP
2002-04-10Efficacy · Supplement 7 · standard — Label ↗AP
2002-04-10Labeling · Supplement 5 · standard — Label ↗AP
2002-04-10Labeling · Supplement 4 · standard — Letter ↗AP
2001-12-08Labeling · Supplement 3 · standard — Label ↗AP
2000-07-18Manufacturing (CMC) · Supplement 6 · standardAP
1998-11-03Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-19Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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