Details for New Drug Application (NDA): 203167
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NDA 203167 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Dr Reddys Labs Sa, 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, Unichem, Url Labs, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-seven NDAs. It is available from forty-two suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.
The generic ingredient in CLONIDINE HYDROCHLORIDE 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 HYDROCHLORIDE 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 203167
| Tradename: | CLONIDINE HYDROCHLORIDE |
| Applicant: | Xgen Pharms |
| Ingredient: | clonidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203167
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 203167
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | INJECTABLE;INJECTION | 203167 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-2000 | 39822-2000-1 | 10 mL in 1 VIAL, SINGLE-DOSE (39822-2000-1) |
| CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | INJECTABLE;INJECTION | 203167 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-2010 | 39822-2010-1 | 10 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/10ML (0.1MG/ML) | ||||
| Approval Date: | Oct 29, 2013 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/10ML (0.5MG/ML) | ||||
| Approval Date: | Oct 29, 2013 | TE: | AP | RLD: | No | ||||
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