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Chinese Patent Office
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Generated: January 16, 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 Dr Reddys Labs Ltd and is included in one NDA. It is available from two 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. Four 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 43598-606-10 10 SYRINGE in 1 CARTON (43598-606-10) > .8 mL in 1 SYRINGE (43598-606-11)
FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 091316 ANDA Dr. Reddy's Laboratories Inc. 43598-606 43598-606-02 2 SYRINGE in 1 CARTON (43598-606-02) > .8 mL in 1 SYRINGE (43598-606-11)

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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
QuintilesIMS
UBS
Fuji
Mallinckrodt
Novartis
Argus Health
McKesson

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