Details for New Drug Application (NDA): 088636
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NDA 088636 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.
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 088636
| Tradename: | PROCAINAMIDE HYDROCHLORIDE |
| Applicant: | Intl Medication |
| Ingredient: | procainamide hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 088636
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | procainamide hydrochloride | INJECTABLE;INJECTION | 088636 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1630 | 51662-1630-3 | 5 POUCH in 1 CASE (51662-1630-3) / 1 BOX in 1 POUCH (51662-1630-2) / 1 SYRINGE in 1 BOX / 10 mL in 1 SYRINGE |
| PROCAINAMIDE HYDROCHLORIDE | procainamide hydrochloride | INJECTABLE;INJECTION | 088636 | ANDA | REMEDYREPACK INC. | 70518-4208 | 70518-4208-0 | 5 SYRINGE in 1 PACKAGE (70518-4208-0) / 10 mL in 1 SYRINGE (70518-4208-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Jul 31, 1984 | TE: | AP | RLD: | No | ||||
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