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Details for New Drug Application (NDA): 040858

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NDA 040858 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 thirty-nine 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: 040858

Heritage Pharms Inc
hydralazine hydrochloride
Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Feb 26, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Feb 26, 2010TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Feb 26, 2010TE:RLD:No

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