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Serving leading biopharmaceutical companies globally:

Healthtrust
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Generated: November 25, 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 208114

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0

Suppliers and Packaging for NDA: 208114

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFITELIO
defibrotide sodium
SOLUTION;IV (INFUSION) 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 68727-800-01 2.5 mL in 1 VIAL (68727-800-01)
DEFITELIO
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 leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Fuji
Cantor Fitzgerald
McKesson
Boehringer Ingelheim
Cipla
Citi
UBS
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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