Details for New Drug Application (NDA): 088636
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The generic ingredient in PROCAINAMIDE HYDROCHLORIDE is procainamide hydrochloride. There are nine drug master file entries for this compound. Five 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 |
Formulation / Manufacturing: | see details |
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 | International Medication Systems, Limited | 76329-3399 | 76329-3399-5 | 5 SYRINGE in 1 PACKAGE (76329-3399-5) / 10 mL in 1 SYRINGE |
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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