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Clonidine hydrochloride - Generic Drug Details

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Clonidine hydrochloride is the generic ingredient in five branded drugs marketed by Hikma Farmaceutica, Zydus Pharms Usa Inc, Duramed Pharms Barr, Vintage, Teva, Luitpold, Boehringer Ingelheim, Mylan Institutional, Mylan, Actavis Elizabeth, Sun Pharm Inds, Sun Pharm Inds Inc, Concordia Pharms 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. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for clonidine hydrochloride. Fifty-nine suppliers are listed for this compound.

Summary for Generic Name: clonidine hydrochloride

Tradenames:5
Patents:0
Applicants:27
NDAs:55
Drug Master File Entries: see list21
Suppliers / Packaging: see list59
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: clonidine hydrochloride

Clinical Trials for: clonidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anchen Pharms
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL202983-001Apr 2, 2014DISCNNo<disabled><disabled>
Teva
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL070702-001Jul 8, 1986DISCNNo<disabled><disabled>
Unichem
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL078895-003Aug 26, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: clonidine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
CATAPRES
clonidine hydrochloride
TABLET;ORAL017407-002Approved Prior to Jan 1, 19823,454,701<disabled>
Concordia Pharms Inc
JENLOGA
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-001Sep 30, 20095,869,100<disabled>
Concordia Pharms Inc
KAPVAY
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-003Sep 28, 20105,869,100<disabled>
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