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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 203118

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NDA 203118 describes DUTASTERIDE, which is a drug marketed by Acella, Actavis Labs Fl Inc, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Graviti Pharms, Heritage Pharms Inc, Hikma, Humanwell Puracap, Onesource Specialty, Ph Health, Pharmobedient, Rising, Strides Pharma, Zydus Lifesciences, Aurobindo Pharma, and Zydus Pharms, and is included in twenty-three NDAs. It is available from eleven suppliers. Additional details are available on the DUTASTERIDE profile page.

The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for 203118

Tradename:	DUTASTERIDE
Applicant:	Amneal Pharms
Ingredient:	dutasteride
Patents:	0

Pharmacology for NDA: 203118

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 203118

5-alpha Reductase Inhibitors

Suppliers and Packaging for NDA: 203118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DUTASTERIDE	dutasteride	CAPSULE;ORAL	203118	ANDA	Amneal Pharmaceuticals LLC	65162-750	65162-750-03	30 CAPSULE in 1 BOTTLE (65162-750-03)
DUTASTERIDE	dutasteride	CAPSULE;ORAL	203118	ANDA	Amneal Pharmaceuticals LLC	65162-750	65162-750-09	90 CAPSULE in 1 BOTTLE (65162-750-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Nov 20, 2015	TE:	AB	RLD:	No

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