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Details for New Drug Application (NDA): 089438

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NDA 089438 describes PROCAINAMIDE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Ivax Sub Teva Pharms, Ani Pharms Inc, Abraxis Pharm, Idt Australia Ltd, Pharmafair, Warner Chilcott, Eurohlth Intl Sarl, Smith And Nephew, Solopak, Intl Medication, Hospira, Inwood Labs, Ascot, Lederle, Vangard, Sandoz, Roxane, and Lannett, and is included in sixty-one NDAs. It is available from three suppliers. Additional details are available on the PROCAINAMIDE HYDROCHLORIDE profile page.

The generic ingredient in PROCAINAMIDE HYDROCHLORIDE is procainamide hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.

Summary for NDA: 089438

Ani Pharms Inc
procainamide hydrochloride
Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Mar 23, 1987TE:RLD:No

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