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Generated: November 21, 2018

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Details for New Drug Application (NDA): 019841

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NDA 019841 describes INDIUM IN 111 CHLORIDE, which is a drug marketed by Mallinkrodt Nuclear and is included in one NDA. It is available from one supplier. Additional details are available on the INDIUM IN 111 CHLORIDE profile page.

The generic ingredient in INDIUM IN 111 CHLORIDE is indium in-111 chloride. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 chloride profile page.
Summary for 019841
Applicant:Mallinkrodt Nuclear
Ingredient:indium in-111 chloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019841
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDIUM IN 111 CHLORIDE indium in-111 chloride INJECTABLE;INJECTION 019841 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-132 69945-132-06 1 VIAL, GLASS in 1 CAN (69945-132-06) > .5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5mCi/0.5ML
Approval Date:Sep 27, 1994TE:RLD:Yes

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