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Details for New Drug Application (NDA): 074823

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NDA 074823 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Sandoz, Jubilant Cadista, Ranbaxy Labs Ltd, Mylan, Teva, Mylan Technologies, and Apotex, and is included in twelve NDAs. It is available from twenty-five 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. Twenty-five suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.

Summary for NDA: 074823

terazosin hydrochloride
Therapeutic Class:Cardiovascular Agents
Genitourinary Agents

Pharmacology for NDA: 074823

Mechanism of ActionAdrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 074823

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
terazosin hydrochloride
CAPSULE;ORAL 074823 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1337 0615-1337-39 30 CAPSULE in 1 BLISTER PACK (0615-1337-39)
terazosin hydrochloride
CAPSULE;ORAL 074823 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1338 0615-1338-39 30 CAPSULE in 1 BLISTER PACK (0615-1338-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Mar 30, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Mar 30, 1998TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Mar 30, 1998TE:ABRLD:No

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