ERWINASE

ERWINASE

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

Company

DUNS: 220514820

Effective Date

June 15, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments1

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

Labeler

Porton Biopharma Limited

DUNS Number

220514820

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

NDC Product Code

81561-413

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Effective Date

May 3, 2021

Ingredients

Code: D733ET3F9OClass: ACTIBQuantity: 10000 [iU] in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 0.5 mg in 1 mL

DEXTROSE MONOHYDRATEInactive

Code: LX22YL083GClass: IACTQuantity: 5 mg in 1 mL