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FDA Approval

INDIUM IN 111 CHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Curium US LLC
DUNS: 079875617
Effective Date
December 19, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Indium In-111 chloride(10 mCi in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

INDIUM IN 111 CHLORIDE

Product Details

NDC Product Code
69945-132
Application Number
NDA019841
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 19, 2019
Code: 58TD96H03IClass: ACTIMQuantity: 10 mCi in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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