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Details for New Drug Application (NDA): 089532

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NDA 089532 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, Frontida Biopharm, Akorn, Abraxis Pharm, Luitpold, Par Pharm, Alkem Labs Ltd, Ivax Sub Teva Pharms, Navinta Llc, West Ward, Sandoz, 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 NDAs. It is available from forty suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

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

Summary for NDA: 089532

Tradename:
HYDRALAZINE HYDROCHLORIDE
Applicant:
Abraxis Pharm
Ingredient:
hydralazine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Aug 11, 1987TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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