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Details for New Drug Application (NDA): 070976

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NDA 070976 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by Hikma Farmaceutica, Zydus Pharms Usa Inc, Duramed Pharms Barr, Vintage, 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, Dava Pharms Inc, Aurolife Pharma Llc, Unichem, Carlsbad, and Impax Labs, and is included in fifty-five NDAs. It is available from fifty-five suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.

The generic ingredient in CLONIDINE HYDROCHLORIDE is chlorthalidone; clonidine hydrochloride. There are fifteen 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: 070976

Tradename:
CLONIDINE HYDROCHLORIDE
Applicant:
Actavis Elizabeth
Ingredient:
clonidine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 070976

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 070976

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL 070976 ANDA Actavis Pharma, Inc. 0228-2129 0228-2129-10 100 TABLET in 1 BOTTLE (0228-2129-10)
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL 070976 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2574 0615-2574-39 30 TABLET in 1 BLISTER PACK (0615-2574-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Dec 16, 1986TE:ABRLD:No


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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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