Details for New Drug Application (NDA): 209552
✉ Email this page to a colleague
The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 209552
Tradename: | ARGATROBAN IN SODIUM CHLORIDE |
Applicant: | Eugia Pharma Speclts |
Ingredient: | argatroban |
Patents: | 0 |
Pharmacology for NDA: 209552
Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 209552
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARGATROBAN IN SODIUM CHLORIDE | argatroban | SOLUTION;INTRAVENOUS | 209552 | NDA | Eugia US LLC | 55150-241 | 55150-241-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE |
ARGATROBAN IN SODIUM CHLORIDE | argatroban | SOLUTION;INTRAVENOUS | 209552 | NDA | Eugia US LLC | 55150-241 | 55150-241-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/50ML (1MG/ML) | ||||
Approval Date: | Nov 27, 2018 | TE: | RLD: | No |
Complete Access Available with Subscription