Details for New Drug Application (NDA): 022499
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NDA 022499 describes CLONIDINE, which is a drug marketed by Tris Pharma Inc, Actavis Labs Ut Inc, Aveva, 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, Anchen Pharms, Bluepharma Industria, Chartwell Rx, Jubilant Generics, Novast Labs, 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, Unichem, Url Labs, 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.
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 022499
| Tradename: | CLONIDINE |
| Applicant: | Tris Pharma Inc |
| Ingredient: | clonidine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 022499
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | EQ 0.09MG BASE/ML | ||||
| Approval Date: | Dec 3, 2009 | TE: | RLD: | No | |||||
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