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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. Sixty suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

Summary for NDA: 020615

Mylan Institutional
clonidine hydrochloride
Therapeutic Class:Cardiovascular Agents

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
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
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:No

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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