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Generated: May 21, 2019

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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 204781
Tradename:DOTAREM
Applicant:Guerbet
Ingredient:gadoterate meglumine
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204781
Generic Entry Date for 204781*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 67684-2000-4 6 VIAL in 1 PACKAGE (67684-2000-4) > 100 mL in 1 VIAL
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

Profile 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:Aug 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Profile 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:Aug 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5.6535GM/15ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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