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Generated: November 16, 2018

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Details for New Drug Application (NDA): 084291

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NDA 084291 describes HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE, which is a drug marketed by Ivax Sub Teva Pharms and is included in one NDA. Additional details are available on the HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;15MG;0.1MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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