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Generated: October 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091368

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NDA 091368 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by Hikma Farmaceutica, Zydus Pharms Usa Inc, Duramed Pharms Barr, Prinston Inc, Teva, Luitpold, Mylan, Actavis Elizabeth, Frontida Biopharm, Sun Pharm Inds Inc, Warner Chilcott, Interpharm, Par Pharm, Watson Labs, Exela Pharma Scs Llc, Alembic Pharms Ltd, Fresenius Kabi Usa, Am Therap, Anchen Pharms, Chartwell Molecules, Aurolife Pharma Llc, Unichem, Yung Shin Pharm, and Impax Labs, and is included in fifty-three NDAs. It is available from fifty-six 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 NDA: 091368

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

Pharmacology for NDA: 091368

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 091368

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL 091368 ANDA A-S Medication Solutions 50090-2983 50090-2983-1 60 TABLET in 1 BOTTLE (50090-2983-1)
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL 091368 ANDA Alembic Pharmaceuticals Inc. 62332-054 62332-054-10 100 TABLET in 1 CARTON (62332-054-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Dec 6, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Dec 6, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Dec 6, 2011TE:ABRLD:No


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