Indium In 111 Oxyquinoline

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

Company

DUNS: 203794185

Effective Date

May 5, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Products1

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

NDC Product Code

72536-0920

Application Number

ANDA202586

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

July 5, 2019

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7.5 mg in 1 mL

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 100 ug in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

Code: LGX9OL562TClass: ACTIMQuantity: 1 mCi in 1 mL

HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACIDInactive

Code: RWW266YE9IClass: IACTQuantity: 6 mg in 1 mL