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Generated: January 23, 2019

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Details for New Drug Application (NDA): 019044

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NDA 019044 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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the indium in-111 oxyquinoline profile page.
Summary for 019044
Applicant:Ge Healthcare
Ingredient:indium in-111 oxyquinoline
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDIUM IN 111 OXYQUINOLINE indium in-111 oxyquinoline INJECTABLE;INJECTION 019044 NDA Medi-Physics Inc. dba GE Healthcare. 17156-021 17156-021-01 1 VIAL in 1 BOX (17156-021-01) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1mCi/ML
Approval Date:Dec 24, 1985TE:RLD:Yes

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