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Last Updated: December 5, 2019

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Details for New Drug Application (NDA): 202586

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NDA 202586 describes INDIUM IN 111 OXYQUINOLINE, which is a drug marketed by Bwxt Itg and Ge Healthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the INDIUM IN 111 OXYQUINOLINE profile page.

The generic ingredient in INDIUM IN 111 OXYQUINOLINE is indium in-111 oxyquinoline. There are twenty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 oxyquinoline profile page.
Summary for 202586
Applicant:Bwxt Itg
Ingredient:indium in-111 oxyquinoline
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202586
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDIUM IN 111 OXYQUINOLINE indium in-111 oxyquinoline INJECTABLE;INJECTION 202586 ANDA BWXT ITG Canada, Inc. 72536-0920 72536-0920-1 1 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1mCi/ML
Approval Date:Jul 25, 2018TE:RLD:No

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