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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202158

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NDA 202158 describes RADIOGENIX SYSTEM, which is a drug marketed by Northstar Medical and is included in one NDA. It is available from one supplier. Additional details are available on the RADIOGENIX SYSTEM profile page.

The generic ingredient in RADIOGENIX SYSTEM 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 202158
Applicant:Northstar Medical
Ingredient:technetium tc-99m sodium pertechnetate generator
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202158
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RADIOGENIX SYSTEM technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC 202158 NDA NorthStar Medical Radioisotopes, LLC 71612-006 71612-006-01 1 Ci in 1 CARTON (71612-006-01)

Profile for product number 001

Approval Date:Feb 8, 2018TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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