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Serving leading biopharmaceutical companies globally:

Novartis
Cipla
Teva
Mallinckrodt
Harvard Business School
Healthtrust
Dow
Colorcon
UBS
Cerilliant

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204781

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NDA 204781 describes DOTAREM, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the DOTAREM profile page.

The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this compound. Additional details are available on the gadoterate meglumine profile page.

Summary for NDA: 204781

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204781

Suppliers and Packaging for NDA: 204781

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOTAREM
gadoterate meglumine
SOLUTION;INTRAVENOUS 204781 NDA Guerbet LLC 67684-2000 67684-2000-0 10 VIAL in 1 PACKAGE (67684-2000-0) > 5 mL in 1 VIAL
DOTAREM
gadoterate meglumine
SOLUTION;INTRAVENOUS 204781 NDA Guerbet LLC 67684-2000 67684-2000-1 10 VIAL in 1 PACKAGE (67684-2000-1) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength37.69GM/100ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 20, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength3.769GM/10ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 20, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Serving leading biopharmaceutical companies globally:

Novartis
Johnson and Johnson
UBS
Chinese Patent Office
Fuji
Moodys
Citi
Julphar
Argus Health
Accenture

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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