Details for New Drug Application (NDA): 089369
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NDA 089369 describes PROCAINAMIDE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Abraxis Pharm, Caplin, 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 sixty NDAs. It is available from nine 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. Nine suppliers are listed for this compound. 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. Nine suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.
Summary for 089369
| Tradename: | PROCAINAMIDE HYDROCHLORIDE |
| Applicant: | Ani Pharms |
| Ingredient: | procainamide hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 089369
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 250MG | ||||
| Approval Date: | Aug 14, 1987 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jan 9, 1987 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
| Approval Date: | Aug 14, 1987 | TE: | RLD: | No | |||||
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