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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200300


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NDA 200300 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, Anchen Pharms, Bluepharma Industria, Dr Reddys Labs Sa, Jubilant Generics, Lupin Ltd, 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 fifty-seven NDAs. It is available from thirty-nine 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.
Summary for 200300
Tradename:CLONIDINE HYDROCHLORIDE
Applicant:Hikma Farmaceutica
Ingredient:clonidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200300
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 200300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200300 ANDA Hikma Pharmaceuticals USA Inc. 0143-9723 0143-9723-01 10 mL in 1 VIAL, SINGLE-USE (0143-9723-01)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 200300 ANDA Hikma Pharmaceuticals USA Inc. 0143-9724 0143-9724-01 10 mL in 1 VIAL, SINGLE-USE (0143-9724-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Jan 26, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/10ML (0.5MG/ML)
Approval Date:Jan 26, 2011TE:APRLD:No

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