MedPath
FDA Product

Radiogardase

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Radiogardase

58060-002

Regulatory Information

58060-002

NDA021626

C73594

October 7, 2021

USA

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2003

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

317151645

Active Ingredients

GELATIN

Quantity: 83.12 mg in 1 1

Code: 2G86QN327L

Class Code: IACT

WATER

Quantity: 14.21 mg in 1 1

Code: 059QF0KO0R

Class Code: IACT

SODIUM LAURYL SULFATE

Quantity: 0.15 mg in 1 1

Code: 368GB5141J

Class Code: IACT

FERRIC FERROCYANIDE

Quantity: 500 mg in 1 1

Code: TLE294X33A

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Quantity: 38 mg in 1 1

Code: OP1R32D61U

Class Code: IACT

INDIGOTINDISULFONATE SODIUM

Quantity: 0.67 mg in 1 1

Code: D3741U8K7L

Class Code: IACT

Active Moieties

FERRIC FERROCYANIDE

Code: TLE294X33A

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