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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Johnson and Johnson
Harvard Business School
US Army

Generated: September 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208114

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NDA 208114 describes DEFITELIO, which is a drug marketed by Jazz Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DEFITELIO profile page.

The generic ingredient in DEFITELIO is defibrotide sodium. One supplier is listed for this compound. Additional details are available on the defibrotide sodium profile page.

Summary for NDA: 208114


Suppliers and Packaging for NDA: 208114

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
defibrotide sodium
SOLUTION;IV (INFUSION) 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 68727-800-01 2.5 mL in 1 VIAL (68727-800-01)
defibrotide sodium
SOLUTION;IV (INFUSION) 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 68727-800-02 25 mL in 1 CARTON (68727-800-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength200MG/2.5ML (80MG/ML)
Approval Date:Mar 30, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 30, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Mar 30, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Boehringer Ingelheim
Daiichi Sankyo
Farmers Insurance

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