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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 090873


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NDA 090873 describes CLONIDINE, which is a drug marketed by Tris Pharma Inc, Actavis Labs Ut Inc, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Endo Operations, Jubilant Generics, Novast Labs, Somerset Theraps Llc, Xiamen Lp Pharm Co, Alembic Pharms Ltd, Am Therap, Aurobindo Pharma Ltd, Chartwell Molecules, Duramed Pharms Barr, Impax Labs, Interpharm, Par Pharm, Prinston Inc, Rising, Sun Pharm Inds Inc, Teva, Trupharma, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in sixty-two NDAs. It is available from four suppliers. Additional details are available on the CLONIDINE profile page.

The generic ingredient in CLONIDINE is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.
Summary for 090873
Tradename:CLONIDINE
Applicant:Actavis Labs Ut Inc
Ingredient:clonidine
Patents:0
Pharmacology for NDA: 090873
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 090873
Suppliers and Packaging for NDA: 090873
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE clonidine SYSTEM;TRANSDERMAL 090873 ANDA Actavis Pharma, Inc. 0591-3508 0591-3508-04 4 POUCH in 1 CARTON (0591-3508-04) / 1 PATCH in 1 POUCH (0591-3508-54) / 7 d in 1 PATCH
CLONIDINE clonidine SYSTEM;TRANSDERMAL 090873 ANDA Actavis Pharma, Inc. 0591-3509 0591-3509-04 4 POUCH in 1 CARTON (0591-3509-04) / 1 PATCH in 1 POUCH (0591-3509-54) / 7 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYSTEM;TRANSDERMALStrength0.1MG/24HR
Approval Date:May 6, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SYSTEM;TRANSDERMALStrength0.2MG/24HR
Approval Date:May 6, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SYSTEM;TRANSDERMALStrength0.3MG/24HR
Approval Date:May 6, 2014TE:ABRLD:No

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