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Queensland Health
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Express Scripts
Moodys
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075140

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NDA 075140 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-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 075140
Tradename:TERAZOSIN HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:terazosin hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075140
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 075140
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075140 ANDA Mylan Pharmaceuticals Inc. 0378-1570 N 0378-1570-01
TERAZOSIN HYDROCHLORIDE terazosin hydrochloride CAPSULE;ORAL 075140 ANDA Mylan Pharmaceuticals Inc. 0378-2260 N 0378-2260-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Feb 11, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Feb 11, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Feb 11, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Department of Justice
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Chubb
US Army
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Federal Trade Commission

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