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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204262


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NDA 204262 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 204262
Tradename:DUTASTERIDE
Applicant:Strides Pharma
Ingredient:dutasteride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204262
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 204262
Suppliers and Packaging for NDA: 204262
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 204262 ANDA Strides Pharma Science Limited 64380-763 64380-763-04 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-04)
DUTASTERIDE dutasteride CAPSULE;ORAL 204262 ANDA Strides Pharma Science Limited 64380-763 64380-763-05 90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Nov 20, 2015TE:ABRLD:No

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