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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202509


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NDA 202509 describes DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma, Endo Operations, and Zydus Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE profile page.

The generic ingredient in DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 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 202509
Pharmacology for NDA: 202509
Suppliers and Packaging for NDA: 202509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202509 ANDA Endo USA, Inc. 10370-280 10370-280-09 90 CAPSULE in 1 BOTTLE (10370-280-09)
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202509 ANDA Endo USA, Inc. 10370-280 10370-280-11 30 CAPSULE in 1 BOTTLE (10370-280-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG;0.4MG
Approval Date:Feb 26, 2014TE:ABRLD:No

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