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Generated: November 17, 2018

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Details for New Drug Application (NDA): 017771

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NDA 017771 describes TECHNELITE, which is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNELITE profile page.

The generic ingredient in TECHNELITE 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 017771
Tradename:TECHNELITE
Applicant:Lantheus Medcl
Ingredient:technetium tc-99m sodium pertechnetate generator
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017771
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771 NDA Lantheus Medical Imaging, Inc. 11994-090 11994-090-01 1 VIAL in 1 CARTON (11994-090-01) > 12 mL in 1 VIAL
TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771 NDA Lantheus Medical Imaging, Inc. 11994-090 11994-090-03 1 VIAL in 1 CARTON (11994-090-03) > 16 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength0.0083-2.7 CI/GENERATOR
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1-20 CI/GENERATOR
Approval Date:Feb 12, 2014TE:RLD:Yes

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