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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 one supplier. 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 NDA: 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 Limited 55111-678 55111-678-02 2 SYRINGE in 1 CARTON (55111-678-02) > .5 mL in 1 SYRINGE (55111-678-11)
FONDAPARINUX SODIUM
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS 091316 ANDA Dr. Reddy's Laboratories Limited 55111-678 55111-678-10 10 SYRINGE in 1 CARTON (55111-678-10) > .5 mL in 1 SYRINGE (55111-678-11)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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