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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Colorcon
Queensland Health
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200300

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NDA 200300 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 fifty-one 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 200300
Tradename:CLONIDINE HYDROCHLORIDE
Applicant:Hikma Farmaceutica
Ingredient:clonidine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200300
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 200300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200300 ANDA West-ward Pharmaceutical Corp 0143-9723 N 0143-9723-01
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200300 ANDA West-ward Pharmaceutical Corp 0143-9724 N 0143-9724-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Jan 26, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/10ML (0.5MG/ML)
Approval Date:Jan 26, 2011TE:APRLD:No

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