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Generated: December 18, 2018

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Details for New Drug Application (NDA): 078098

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NDA 078098 describes TECHNETIUM TC 99M SESTAMIBI, which is a drug marketed by Cardinal Health 414, Jubilant Draximage, Mallinkrodt Nuclear, and Pharmalucence, and is included in four NDAs. It is available from four 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 078098
Tradename:TECHNETIUM TC 99M SESTAMIBI
Applicant:Mallinkrodt Nuclear
Ingredient:technetium tc-99m sestamibi kit
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078098
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 078098 ANDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-092 69945-092-20 5 VIAL in 1 CELLO PACK (69945-092-20) > 10 mL in 1 VIAL
TECHNETIUM TC 99M SESTAMIBI technetium tc-99m sestamibi kit INJECTABLE;INJECTION 078098 ANDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-092 69945-092-40 30 VIAL in 1 CARTON (69945-092-40) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Sep 22, 2008TE:APRLD:No

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