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Healthtrust
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Harvard Business School
Federal Trade Commission
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075317

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NDA 075317 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Apotex, Ivax Sub Teva Pharms, Jubilant Cadista, Mylan Pharms Inc, Mylan Technologies, Ranbaxy Labs Ltd, Sandoz, and Teva, and is included in twelve NDAs. It is available from twenty-two 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-two suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 075317
Tradename:TERAZOSIN HYDROCHLORIDE
Applicant:Jubilant Cadista
Ingredient:terazosin hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075317
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 075317
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075317 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-227 N 49999-227-30
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075317 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-227 N 49999-227-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Dec 20, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Dec 20, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Dec 20, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Dow
Johnson and Johnson
US Army
Medtronic
McKinsey
Chubb
AstraZeneca
Boehringer Ingelheim

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