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Generated: June 26, 2019

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Details for New Drug Application (NDA): 017693

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NDA 017693 describes TECHNETIUM TC 99M GENERATOR, which is a drug marketed by Ge Healthcare and is included in one NDA. Additional details are available on the TECHNETIUM TC 99M GENERATOR profile page.

The generic ingredient in TECHNETIUM TC 99M GENERATOR is technetium tc-99m sodium pertechnetate generator. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate generator profile page.
Summary for 017693
Tradename:TECHNETIUM TC 99M GENERATOR
Applicant:Ge Healthcare
Ingredient:technetium tc-99m sodium pertechnetate generator
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUS, ORALStrength830-16600mCi/GENERATOR
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUS, ORALStrength68-2703mCi/GENERATOR
Approval Date:Dec 13, 2013TE:RLD:Yes

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