Details for New Drug Application (NDA): 206918
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The generic ingredient in FONDAPARINUX SODIUM is fondaparinux sodium. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.
Summary for 206918
Tradename: | FONDAPARINUX SODIUM |
Applicant: | Eugia Pharma |
Ingredient: | fondaparinux sodium |
Patents: | 0 |
Pharmacology for NDA: 206918
Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 206918
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 206918 | ANDA | Eugia US LLC | 55150-230 | 55150-230-02 | 2 SYRINGE, GLASS in 1 CARTON (55150-230-02) / .5 mL in 1 SYRINGE, GLASS (55150-230-00) |
FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 206918 | ANDA | Eugia US LLC | 55150-230 | 55150-230-10 | 10 SYRINGE, GLASS in 1 CARTON (55150-230-10) / .5 mL in 1 SYRINGE, GLASS (55150-230-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 2.5MG/0.5ML | ||||
Approval Date: | Dec 26, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 5MG/0.4ML | ||||
Approval Date: | Dec 26, 2017 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 7.5MG/0.6ML | ||||
Approval Date: | Dec 26, 2017 | TE: | AP | RLD: | No |
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