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Details for New Drug Application (NDA): 083145

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NDA 083145 describes RESERPINE, which is a drug marketed by Watson Labs, Tablicaps, Pvt Form, Teva, Barr, Whiteworth Town Plsn, Mk Labs, Impax Labs, Rexall, Sandoz, Everylife, Elkins Sinn, Solvay, Purepac Pharm, Halsey, Bell Pharma, Cycle Pharms Ltd, Bundy, Pharmavite, Valeant Pharm Intl, Mylan, Hikma Intl Pharms, Ivax Sub Teva Pharms, Marshall Pharma, West Ward, Par Pharm, Ivax Pharms, Sun Pharm Inds, and Lederle, and is included in forty-one NDAs. It is available from one supplier. Additional details are available on the RESERPINE profile page.

The generic ingredient in RESERPINE 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: 083145

Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.1MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No