Details for New Drug Application (NDA): 208615
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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 208615
Tradename: | FONDAPARINUX SODIUM |
Applicant: | Scinopharm Taiwan |
Ingredient: | fondaparinux sodium |
Patents: | 0 |
Pharmacology for NDA: 208615
Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 208615
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 208615 | ANDA | Italfarmaco S.p.A | 11797-154 | 11797-154-06 | 10 SYRINGE in 1 CARTON (11797-154-06) / .5 mL in 1 SYRINGE (11797-154-02) |
FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 208615 | ANDA | Italfarmaco S.p.A | 11797-154 | 11797-154-09 | 2 SYRINGE in 1 CARTON (11797-154-09) / .5 mL in 1 SYRINGE (11797-154-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 2.5MG/0.5ML | ||||
Approval Date: | Nov 14, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 5MG/0.4ML | ||||
Approval Date: | Nov 14, 2018 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 7.5MG/0.6ML | ||||
Approval Date: | Nov 14, 2018 | TE: | AP | RLD: | No |
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