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Details for New Drug Application (NDA): 200300

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NDA 200300 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by 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 fifty-five NDAs. It is available from fifty-six suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.

The generic ingredient in CLONIDINE HYDROCHLORIDE 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: 200300

Hikma Farmaceutica
clonidine hydrochloride
Therapeutic Class:Cardiovascular Agents

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
INJECTABLE;INJECTION 200300 ANDA West-ward Pharmaceutical Corp 0143-9723 0143-9723-01 10 mL in 1 VIAL, SINGLE-USE (0143-9723-01)
clonidine hydrochloride
INJECTABLE;INJECTION 200300 ANDA West-ward Pharmaceutical Corp 0143-9724 0143-9724-01 10 mL in 1 VIAL, SINGLE-USE (0143-9724-01)

Summary for product number 001

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

Summary 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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