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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091104

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NDA 091104 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, 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-six NDAs. It is available from sixty-five suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.

The generic ingredient in CLONIDINE HYDROCHLORIDE is chlorthalidone; clonidine hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.
Summary for 091104
Ingredient:clonidine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091104
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 091104
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 091104 ANDA American Regent, Inc. 0517-0730 N 0517-0730-01
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 091104 ANDA American Regent, Inc. 0517-0731 N 0517-0731-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Oct 8, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/10ML (0.5MG/ML)
Approval Date:Oct 8, 2009TE:APRLD:No

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