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Last Updated: April 1, 2025

Details for New Drug Application (NDA): 207935

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NDA 207935 describes DUTASTERIDE, which is a drug marketed by Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Heritage Pharms Inc, Hikma, Humanwell Puracap, Norvium Bioscience, Nostrum Labs Inc, Rising, Strides Pharma, Strides Softgels, Vintage, Zydus Lifesciences, Aurobindo Pharma, Endo Operations, and Zydus Pharms, and is included in twenty-three NDAs. It is available from fourteen 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. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for 207935

Tradename:	DUTASTERIDE
Applicant:	Heritage Pharms Inc
Ingredient:	dutasteride
Patents:	0

Medical Subject Heading (MeSH) Categories for 207935

5-alpha Reductase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Oct 13, 2017	TE:		RLD:	No

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