Last Updated: May 11, 2026

Details for New Drug Application (NDA): 074315

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NDA 074315 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Pharmobedient, Ranbaxy Labs Ltd, Senores Pharms, 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 074315

Tradename:	TERAZOSIN HYDROCHLORIDE
Applicant:	Sandoz
Ingredient:	terazosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Dec 31, 1998	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Dec 31, 1998	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Dec 31, 1998	TE:		RLD:	No

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