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Federal Trade Commission
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200737

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NDA 200737 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 200737
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Alkem Labs Ltd
Ingredient:hydralazine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200737
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 200737
Suppliers and Packaging for NDA: 200737
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200737 ANDA Ascend Laboratories, LLC 67877-290 N 67877-290-01
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200737 ANDA Ascend Laboratories, LLC 67877-290 N 67877-290-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 7, 2012TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 7, 2012TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 7, 2012TE:AARLD:No

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Deloitte
Colorcon
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Fuji
McKesson
Dow
Fish and Richardson
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Merck

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