← FDA DRUG APPROVALS

FDA NDA · NDA022460

JALYN

dutasteride and tamsulosin hydrochloride

Sponsor: WAYLIS THERAP

APPLICATION
NDA022460
TYPE
NDA
ORIGINAL APPROVAL
2010-06-14
LATEST ACTION
2020-12-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

JALYN · ReferencePrescription
DUTASTERIDE 0.5MG, TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL

Approval history

2020-12-29Labeling · Supplement 11 · standard — Label ↗AP
2017-11-01Labeling · Supplement 7 · standard — Label ↗AP
2017-11-01Labeling · Supplement 8 · standard — Label ↗AP
2016-06-13Manufacturing (CMC) · Supplement 9 · standardAP
2013-04-25Labeling · Supplement 5 · standard — Label ↗AP
2013-04-25Labeling · Supplement 3 · unknown — Letter ↗AP
2013-04-25Labeling · Supplement 4 · unknown — Label ↗AP
2012-06-27Labeling · Supplement 2 · unknown — Letter ↗AP
2011-06-09Labeling · Supplement 1 · unknown — Letter ↗AP
2010-06-14Type 4 - New Combination · Original · standard — Summary 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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