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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 089438


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NDA 089438 describes PROCAINAMIDE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Abraxis Pharm, Gland Pharma Ltd, Hikma, Hospira, Intl Medication, Nexus, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, and Sandoz, and is included in fifty-nine NDAs. It is available from seven 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. Seven suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.
Summary for 089438
Tradename:PROCAINAMIDE HYDROCHLORIDE
Applicant:Ani Pharms
Ingredient:procainamide hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 089438

Profile for product number 001

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

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