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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078098

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NDA 078098 describes TECHNETIUM TC-99M SESTAMIBI, which is a drug marketed by Mallinkrodt Nuclear and is included in one NDA. It is available from one supplier. 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 N 69945-092-40
TECHNETIUM TC-99M SESTAMIBI technetium tc-99m sestamibi kit INJECTABLE;INJECTION 078098 ANDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-092 N 69945-092-20

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

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