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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077901

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NDA 077901 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 077901

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

Pharmacology for NDA: 077901

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 077901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 077901 ANDA Qualitest Pharmaceuticals 0603-2957 0603-2957-28 500 TABLET in 1 BOTTLE, PLASTIC (0603-2957-28)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 077901 ANDA Qualitest Pharmaceuticals 0603-2957 0603-2957-02 90 TABLET in 1 BOTTLE, PLASTIC (0603-2957-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Mar 9, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Mar 9, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Mar 9, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Federal Trade Commission
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Fish and Richardson
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