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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Healthtrust
Baxter
Colorcon
Queensland Health
Covington
Julphar
Merck

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200673

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NDA 200673 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, X-gen Pharms Inc, 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 200673
Tradename:CLONIDINE HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:clonidine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200673
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 200673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200673 ANDA Fresenius Kabi USA, LLC 63323-405 N 63323-405-10
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200673 ANDA Fresenius Kabi USA, LLC 63323-427 N 63323-427-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Jul 8, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/10ML (0.5MG/ML)
Approval Date:Jul 8, 2011TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Dow
US Army
Express Scripts
Cantor Fitzgerald
McKinsey
Boehringer Ingelheim
Cipla
US Department of Justice

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