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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Boehringer Ingelheim

Generated: December 13, 2017

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

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 DRAXIMAGE LLC 45548-141 45548-141-30 30 VIAL in 1 KIT (45548-141-30) > 10 mL in 1 VIAL
TECHNETIUM TC 99M SESTAMIBI technetium tc-99m sestamibi kit INJECTABLE;INJECTION 078806 ANDA DRAXIMAGE LLC 45548-141 45548-141-05 5 VIAL in 1 KIT (45548-141-05) > 10 mL in 1 VIAL

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Federal Trade Commission

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