Details for New Drug Application (NDA): 218135
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NDA 218135 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 218135
| Tradename: | PROCAINAMIDE HYDROCHLORIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | procainamide hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | procainamide hydrochloride | INJECTABLE;INJECTION | 218135 | ANDA | Gland Pharma Limited | 68083-603 | 68083-603-25 | 25 CARTON in 1 CASE (68083-603-25) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-603-01) / 10 mL in 1 VIAL, MULTI-DOSE |
| PROCAINAMIDE HYDROCHLORIDE | procainamide hydrochloride | INJECTABLE;INJECTION | 218135 | ANDA | Gland Pharma Limited | 68083-604 | 68083-604-25 | 25 VIAL, MULTI-DOSE in 1 CASE (68083-604-25) / 2 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Jul 22, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/ML | ||||
| Approval Date: | Jul 22, 2024 | TE: | AP | RLD: | No | ||||
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