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Generated: November 20, 2018

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Details for New Drug Application (NDA): 017243

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NDA 017243 describes ULTRA-TECHNEKOW FM, 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 ULTRA-TECHNEKOW FM profile page.

The generic ingredient in ULTRA-TECHNEKOW FM is technetium tc-99m sodium pertechnetate generator. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate generator profile page.
Summary for 017243
Tradename:ULTRA-TECHNEKOW FM
Applicant:Mallinkrodt Nuclear
Ingredient:technetium tc-99m sodium pertechnetate generator
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017243
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRA-TECHNEKOW FM technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017243 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-010 69945-010-03 1 INJECTION, SOLUTION in 1 CARTON (69945-010-03)
ULTRA-TECHNEKOW FM technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017243 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-015 69945-015-04 1 INJECTION, SOLUTION in 1 CARTON (69945-015-04)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength0.25-3 CI/GENERATOR
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1-19 CI/GENERATOR
Approval Date:Feb 18, 2014TE:RLD:Yes

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