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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 076021

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NDA 076021 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Apnar Pharma Lp, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Pharmobedient, Ranbaxy Labs Ltd, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in thirteen NDAs. It is available from eighteen suppliers. Additional details are available on the TERAZOSIN HYDROCHLORIDE profile page.

The generic ingredient in TERAZOSIN HYDROCHLORIDE is terazosin hydrochloride. There are twenty-four drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.

Summary for 076021

Tradename:	TERAZOSIN HYDROCHLORIDE
Applicant:	Ranbaxy Labs Ltd
Ingredient:	terazosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Aug 22, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Aug 22, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 22, 2002	TE:		RLD:	No

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