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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078895

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NDA 078895 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 078895

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078895

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 078895

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 078895 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7947 0615-7947-39 30 TABLET in 1 BLISTER PACK (0615-7947-39)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 078895 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7948 0615-7948-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7948-30) > 5 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Aug 26, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Aug 26, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Aug 26, 2009TE:ABRLD:No


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