Details for New Drug Application (NDA): 213300

NDA 213300 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 213300

Tradename:	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Applicant:	Aurobindo Pharma
Ingredient:	dutasteride; tamsulosin hydrochloride
Patents:	0

Pharmacology for NDA: 213300

Mechanism of Action

5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 213300

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	213300	ANDA	Aurobindo Pharma Limited	59651-063	59651-063-30	30 CAPSULE in 1 BOTTLE (59651-063-30)
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	213300	ANDA	Aurobindo Pharma Limited	59651-063	59651-063-90	90 CAPSULE in 1 BOTTLE (59651-063-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG;0.4MG
Approval Date:	Jul 18, 2024	TE:	AB	RLD:	No

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