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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090527

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NDA 090527 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, Sciegen Pharms Inc, Strides Pharma, Superpharm, 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-one 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 090527
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Glenmark Pharms Ltd
Ingredient:hydralazine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090527
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 090527
Suppliers and Packaging for NDA: 090527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 090527 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-944 N 35356-944-30
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 090527 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-944 N 35356-944-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 27, 2009TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 27, 2009TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 27, 2009TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Deloitte
Daiichi Sankyo
US Department of Justice
Merck
Farmers Insurance
Julphar
McKinsey
Accenture

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