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Details for New Drug Application (NDA): 090873

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NDA 090873 describes CLONIDINE, which is a drug marketed by Tris Pharma Inc, Aveva, Mylan Technologies, Actavis Labs Ut Inc, Mayne Pharma, 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 sixty-one NDAs. It is available from seven suppliers. Additional details are available on the CLONIDINE profile page.

The generic ingredient in CLONIDINE 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: 090873

Actavis Labs Ut Inc

Pharmacology for NDA: 090873

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 090873

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FILM, EXTENDED RELEASE;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
FILM, EXTENDED RELEASE;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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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