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Details for New Drug Application (NDA): 019862

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NDA 019862 describes INDICLOR, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the INDICLOR profile page.

The generic ingredient in INDICLOR is indium in-111 chloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the indium in-111 chloride profile page.

Summary for NDA: 019862

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
indium in-111 chloride
INJECTABLE;INJECTION 019862 NDA Medi-Physics Inc. 17156-523 17156-523-01 1 VIAL, SINGLE-DOSE in 1 CONTAINER (17156-523-01) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2mCi/0.2ML
Approval Date:Dec 29, 1992TE:RLD:Yes

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