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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200770

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NDA 200770 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 thirty-seven 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 200770
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Strides Pharma
Ingredient:hydralazine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200770
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 200770
Suppliers and Packaging for NDA: 200770
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200770 ANDA Strides Shasun Limited 64380-734 N 64380-734-07
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200770 ANDA Strides Shasun Limited 64380-734 N 64380-734-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 3, 2013TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 3, 2013TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 3, 2013TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Boehringer Ingelheim
Argus Health
Fuji
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Merck
Harvard Business School
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