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Serving 500+ biopharmaceutical companies globally:

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Daiichi Sankyo
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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020615

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NDA 020615 describes DURACLON, which is a drug marketed by Mylan Institutional and is included in one NDA. It is available from one supplier. Additional details are available on the DURACLON profile page.

The generic ingredient in DURACLON is clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

Summary for NDA: 020615

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020615

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 020615

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DURACLON
clonidine hydrochloride
INJECTABLE;INJECTION 020615 NDA Mylan Institutional LLC 67457-218 67457-218-10 1 VIAL in 1 CARTON (67457-218-10) > 10 mL in 1 VIAL
DURACLON
clonidine hydrochloride
INJECTABLE;INJECTION 020615 NDA Mylan Institutional LLC 67457-219 67457-219-10 1 VIAL in 1 CARTON (67457-219-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Oct 2, 1996TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/10ML (0.5MG/ML)
Approval Date:Apr 27, 1999TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Teva
Colorcon
McKinsey
Julphar
Citi
UBS
Boehringer Ingelheim
Cantor Fitzgerald
US Army
AstraZeneca

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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