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FDA Approval

Radiogardase

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

FDA Approval Summary

Company
Heyl Chem.-pharm. Fabrik GmbH & Co. KG
DUNS: 317151645
Effective Date
October 7, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prussian blue(500 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

317151645

Manufacturing Establishments4

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Haupt Pharma Wuelfing GmbH

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

333274975

Ostthüringische Materialprüfgesellschaft für Textil- und Kunststoffe mbH

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

332338250

SGS INSTITUT FRESENIUS GmbH

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

341259550

Laborchemie Apolda GmbH

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

Heyl Chem.-pharm. Fabrik GmbH & Co. KG

331821462

Products1

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

Radiogardase

Product Details

NDC Product Code
58060-002
Application Number
NDA021626
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 7, 2021
GELATINInactive
Code: 2G86QN327LClass: IACTQuantity: 83.12 mg in 1 1
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 14.21 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACTQuantity: 0.15 mg in 1 1
Prussian blueActive
Code: TLE294X33AClass: ACTIBQuantity: 500 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACTQuantity: 38 mg in 1 1
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7LClass: IACTQuantity: 0.67 mg in 1 1
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