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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075498

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NDA 075498 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Apnar Pharma Lp, Beximco Pharms Usa, Heritage Pharma, Hikma, Jubilant Cadista, Mylan, Mylan Technologies, Ranbaxy Labs Ltd, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in twelve 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. Eighteen suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 075498
Tradename:TERAZOSIN HYDROCHLORIDE
Applicant:Hikma
Ingredient:terazosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075498
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 075498
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075498 ANDA Aidarex Pharmaceuticals LLC 33261-211 33261-211-30 30 CAPSULE in 1 BOTTLE, PLASTIC (33261-211-30)
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075498 ANDA Aidarex Pharmaceuticals LLC 33261-212 33261-212-30 30 CAPSULE in 1 BOTTLE, PLASTIC (33261-212-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Apr 12, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Apr 12, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Apr 12, 2001TE:ABRLD:No

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