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Serving leading biopharmaceutical companies globally:

Merck
Covington
Baxter
Chubb
US Department of Justice
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Mallinckrodt
Cerilliant
Dow
Cantor Fitzgerald

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204680

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NDA 204680 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Akorn, Fresenius Kabi Usa, Luitpold, Mylan Institutional, Navinta Llc, Smith And Nephew, Solopak, Teva Parenteral, X-gen Pharms Inc, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Strides Pharma, Superpharm, Tech Organized, Upsher-smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, and Ivax Pharms, and is included in ninety-one NDAs. It is available from forty-three suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for 204680

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204680

Physiological EffectArteriolar Vasodilation

Suppliers and Packaging for NDA: 204680

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 204680 ANDA Mylan Institutional LLC 67457-291 67457-291-01 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-291-01) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-291-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Apr 28, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Teva
Cerilliant
Colorcon
Boehringer Ingelheim
US Army
Farmers Insurance
Fish and Richardson
Harvard Business School
Julphar
Novartis

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