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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 090095


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NDA 090095 describes DUTASTERIDE, which is a drug marketed by Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Bionpharma, Heritage Pharms Inc, Hikma, Humanwell Puracap, Mylan, Nostrum Labs Inc, Rising, Strides Pharma, Vintage, Zydus Lifesciences, Anchen Pharms, and Zydus Pharms, and is included in twenty-two NDAs. It is available from sixteen 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 090095
Tradename:DUTASTERIDE
Applicant:Barr
Ingredient:dutasteride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090095

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Dec 21, 2010TE:ABRLD:No

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