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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 020347

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NDA 020347 describes HYTRIN, which is a drug marketed by Abbott and is included in two NDAs. Additional details are available on the HYTRIN profile page.

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

Summary for 020347

Tradename:	HYTRIN
Applicant:	Abbott
Ingredient:	terazosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020347

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994	⤷ Get Started Free	⤷ Get Started Free
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994	⤷ Get Started Free	⤷ Get Started Free
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-002	Dec 14, 1994	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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