Details for New Drug Application (NDA): 091316
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NDA 091316 describes FONDAPARINUX SODIUM, which is a drug marketed by Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan, and is included in five NDAs. It is available from six suppliers. Additional details are available on the FONDAPARINUX SODIUM profile page.
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.
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 091316
| Tradename: | FONDAPARINUX SODIUM |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | fondaparinux sodium |
| Patents: | 0 |
Pharmacology for NDA: 091316
| Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 091316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 091316 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-606 | 43598-606-02 | 2 SYRINGE in 1 CARTON (43598-606-02) / .8 mL in 1 SYRINGE (43598-606-11) |
| FONDAPARINUX SODIUM | fondaparinux sodium | INJECTABLE;SUBCUTANEOUS | 091316 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-606 | 43598-606-10 | 10 SYRINGE in 1 CARTON (43598-606-10) / .8 mL in 1 SYRINGE (43598-606-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 2.5MG/0.5ML | ||||
| Approval Date: | Jul 11, 2011 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 5MG/0.4ML | ||||
| Approval Date: | Jul 11, 2011 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 7.5MG/0.6ML | ||||
| Approval Date: | Jul 11, 2011 | TE: | AP | RLD: | No | ||||
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