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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091316

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NDA 091316 describes FONDAPARINUX SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, and Jiangsu Hengrui Med, and is included in three NDAs. It is available from three 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. Five 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
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 091316
Mechanism of ActionFactor 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 N 43598-606-02
FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 091316 ANDA Dr. Reddy's Laboratories Inc. 43598-606 N 43598-606-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength2.5MG/0.5ML
Approval Date:Jul 11, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength5MG/0.4ML
Approval Date:Jul 11, 2011TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength7.5MG/0.6ML
Approval Date:Jul 11, 2011TE:APRLD:No

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