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Generated: May 27, 2019

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Details for New Drug Application (NDA): 208870

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NDA 208870 describes DRAX EXAMETAZIME, which is a drug marketed by Jubilant Draximage and is included in one NDA. It is available from one supplier. Additional details are available on the DRAX EXAMETAZIME profile page.

The generic ingredient in DRAX EXAMETAZIME is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.
Summary for 208870
Applicant:Jubilant Draximage
Ingredient:technetium tc-99m exametazime kit
Pharmacology for NDA: 208870
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 208870
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRAX EXAMETAZIME technetium tc-99m exametazime kit POWDER;INTRAVENOUS 208870 NDA Jubilant DraxImage Inc. 65174-200 65174-200-05 5 VIAL in 1 CARTON (65174-200-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthN/A
Approval Date:Aug 17, 2017TE:RLD:No

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