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Generated: May 24, 2019

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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-two drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
Summary for 020615
Applicant:Mylan Institutional
Ingredient:clonidine hydrochloride
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

Profile for product number 001

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

Profile 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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