Adagen - 57665-001-01 - (pegademase bovine)

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Drug Information of Adagen

Product NDC: 57665-001
Proprietary Name: Adagen
Non Proprietary Name: pegademase bovine
Active Ingredient(s): 250    [iU]/mL & nbsp;   pegademase bovine
Administration Route(s): INTRAMUSCULAR
Dosage Form(s): INJECTION, SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Adagen

Product NDC: 57665-001
Labeler Name: Sigma-Tau Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019818
Marketing Category: NDA
Start Marketing Date: 20101018

Package Information of Adagen

Package NDC: 57665-001-01
Package Description: 4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE

NDC Information of Adagen

NDC Code 57665-001-01
Proprietary Name Adagen
Package Description 4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE
Product NDC 57665-001
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name pegademase bovine
Dosage Form Name INJECTION, SOLUTION
Route Name INTRAMUSCULAR
Start Marketing Date 20101018
Marketing Category Name NDA
Labeler Name Sigma-Tau Pharmaceuticals, Inc.
Substance Name PEGADEMASE BOVINE
Strength Number 250
Strength Unit [iU]/mL
Pharmaceutical Classes Adenosine Deaminase [Chemical/Ingredient],Bovine Intestinal Adenosine Deaminase [EPC]

Complete Information of Adagen


General Information