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Last Updated: April 17, 2021

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Details for New Drug Application (NDA): 089415

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NDA 089415 describes PROCAINAMIDE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Abraxis Pharm, Hospira, Intl Medication, Nexus Pharms, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, and Sandoz, and is included in fifty-eight NDAs. It is available from four suppliers. Additional details are available on the PROCAINAMIDE HYDROCHLORIDE profile page.

The generic ingredient in PROCAINAMIDE HYDROCHLORIDE is procainamide hydrochloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.
Summary for 089415
Applicant:Abraxis Pharm
Ingredient:procainamide hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 089415

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Nov 17, 1986TE:RLD:No

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