Details for New Drug Application (NDA): 206812
The generic ingredient in FONDAPARINUX SODIUM is fondaparinux sodium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.
Summary for 206812
| Tradename: | FONDAPARINUX SODIUM |
| Applicant: | Hengrui Pharma |
| Ingredient: | fondaparinux sodium |
| Patents: | 0 |
Pharmacology for NDA: 206812
| Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 206812
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FONDAPARINUX SODIUM | fondaparinux sodium | SOLUTION;SUBCUTANEOUS | 206812 | ANDA | Sandoz Inc. | 0781-3443 | 0781-3443-12 | 2 SYRINGE in 1 CARTON (0781-3443-12) / .5 mL in 1 SYRINGE (0781-3443-94) |
| FONDAPARINUX SODIUM | fondaparinux sodium | SOLUTION;SUBCUTANEOUS | 206812 | ANDA | Sandoz Inc. | 0781-3443 | 0781-3443-95 | 10 SYRINGE in 1 CARTON (0781-3443-95) / .5 mL in 1 SYRINGE (0781-3443-94) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 2.5MG/0.5ML (2.5MG/0.5ML) | ||||
| Approval Date: | May 15, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 5MG/0.4ML (5MG/0.4ML) | ||||
| Approval Date: | May 15, 2018 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 7.5MG/0.6ML (7.5MG/0.6ML) | ||||
| Approval Date: | May 15, 2018 | TE: | RLD: | No | |||||
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