Details for New Drug Application (NDA): 076166
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NDA 076166 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.
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 076166
| Tradename: | CLONIDINE |
| Applicant: | Mylan Technologies |
| Ingredient: | clonidine |
| Patents: | 0 |
Pharmacology for NDA: 076166
| Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 076166
Suppliers and Packaging for NDA: 076166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLONIDINE | clonidine | SYSTEM;TRANSDERMAL | 076166 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0871 | 0378-0871-99 | 4 POUCH in 1 CARTON (0378-0871-99) / 1 PATCH in 1 POUCH (0378-0871-16) / 7 d in 1 PATCH |
| CLONIDINE | clonidine | SYSTEM;TRANSDERMAL | 076166 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0872 | 0378-0872-99 | 4 POUCH in 1 CARTON (0378-0872-99) / 1 PATCH in 1 POUCH (0378-0872-16) / 7 d in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.1MG/24HR | ||||
| Approval Date: | Jul 16, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.2MG/24HR | ||||
| Approval Date: | Jul 16, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.3MG/24HR | ||||
| Approval Date: | Jul 16, 2010 | TE: | AB | RLD: | No | ||||
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