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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
Cerilliant
US Army
Dow
Fish and Richardson
Novartis
Deloitte
Covington
McKesson
UBS

Generated: December 13, 2017

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, Anchen Pharms, Lupin Ltd, 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-four NDAs. It is available from fifty-eight suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.

The generic ingredient in CLONIDINE HYDROCHLORIDE is chlorthalidone; clonidine hydrochloride. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.

Summary for 200300

Tradename:1
Applicant:1
Ingredient:1
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 0143-9723-01 10 mL in 1 VIAL, SINGLE-USE (0143-9723-01)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200300 ANDA West-ward Pharmaceutical Corp 0143-9724 0143-9724-01 10 mL in 1 VIAL, SINGLE-USE (0143-9724-01)

Summary for product number 001

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

Summary 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Army
Baxter
Dow
Fuji
Healthtrust
Cantor Fitzgerald
Express Scripts
Julphar
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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