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Serving leading biopharmaceutical companies globally:

US Army
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Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084581

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NDA 084581 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Hetero Labs Ltd Iii, Watson Labs, Mutual Pharm, Vangard, X-gen Pharms Inc, Ascot, Mylan, Solopak, Smith And Nephew, Halsey, Impax Labs, Glenmark Pharms Ltd, Anda Repository, Akorn, Abraxis Pharm, Luitpold, Par Pharm, Tech Organized, Alkem Labs Ltd, Ivax Sub Teva Pharms, Navinta Llc, West Ward, Upsher-smith Labs, Heritage Pharms Inc, Cadila Pharms Ltd, Tg United Labs, Actavis Elizabeth, Usl Pharma, Quantum Pharmics, Invagen Pharms, Pliva, Strides Pharma, Teva Parenteral, Purepac Pharm, Actavis Grp Ptc, Mylan Institutional, Superpharm, Fresenius Kabi Usa, Vitarine, 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 084581

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Colorcon
Chubb
McKinsey
Baxter
Boehringer Ingelheim
Merck
Mallinckrodt
Moodys
McKesson

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