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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078806

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NDA 078806 describes TECHNETIUM TC 99M SESTAMIBI, which is a drug marketed by Cardinal Health 414, Jubilant Draximage, and Pharmalucence, and is included in three NDAs. It is available from three suppliers. Additional details are available on the TECHNETIUM TC 99M SESTAMIBI profile page.

The generic ingredient in TECHNETIUM TC 99M SESTAMIBI is technetium tc-99m sestamibi kit. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the technetium tc-99m sestamibi kit profile page.
Summary for 078806
Tradename:TECHNETIUM TC 99M SESTAMIBI
Applicant:Jubilant Draximage
Ingredient:technetium tc-99m sestamibi kit
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078806
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 078806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TECHNETIUM TC 99M SESTAMIBI technetium tc-99m sestamibi kit INJECTABLE;INJECTION 078806 ANDA Jubilant Draximage (USA) Inc. 45548-141 N 45548-141-30
TECHNETIUM TC 99M SESTAMIBI technetium tc-99m sestamibi kit INJECTABLE;INJECTION 078806 ANDA Jubilant Draximage (USA) Inc. 45548-141 N 45548-141-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Apr 29, 2009TE:APRLD:No

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