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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075667


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NDA 075667 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Apnar Pharma Lp, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Mylan, Mylan Technologies, Ranbaxy Labs Ltd, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in twelve NDAs. It is available from twenty-one 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-one suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 075667
Tradename:TERAZOSIN HYDROCHLORIDE
Applicant:Bionpharma
Ingredient:terazosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075667
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 075667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075667 ANDA Bionpharma Inc. 69452-330 69452-330-20 100 CAPSULE in 1 BOTTLE (69452-330-20)
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075667 ANDA Bionpharma Inc. 69452-331 69452-331-20 100 CAPSULE in 1 BOTTLE (69452-331-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Jul 28, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Jul 28, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 28, 2000TE:ABRLD:No

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