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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078895

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NDA 078895 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by Exela Pharma Scs Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Zydus Pharms Usa Inc, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Anchen Pharms, Jubilant Generics, Lupin Ltd, Mayne Pharma Inc, Xiamen Lp Pharm Co, Alembic Pharms Ltd, Am Therap, Aurolife Pharma Llc, Chartwell Molecules, Duramed Pharms Barr, Frontida Biopharm, Impax Labs, Interpharm, Mylan, Par Pharm, Prinston Inc, Sun Pharm Inds Inc, Teva, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-seven NDAs. It is available from sixty-four suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.

The generic ingredient in CLONIDINE HYDROCHLORIDE is chlorthalidone; clonidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.
Summary for 078895
Tradename:CLONIDINE HYDROCHLORIDE
Applicant:Unichem
Ingredient:clonidine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078895
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 078895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 078895 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7947 N 0615-7947-39
CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 078895 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7948 N 0615-7948-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Aug 26, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Aug 26, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Aug 26, 2009TE:ABRLD:No

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Dow
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Harvard Business School
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