Venofer

Venofer

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

Company

DUNS: 830016429

Effective Date

April 15, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Iron(20 mg in 1 mL)

Manufacturing Establishments1

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

Labeler

A-S Medication Solutions

DUNS Number

830016429

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

NDC Product Code

50090-4541

Application Number

NDA021135

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

October 1, 2020

Ingredients

IronActive

Code: FZ7NYF5N8LClass: ACTIMQuantity: 20 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT