Adagen

Product NDC

57665-001

11-digit product format

576650001

Labeler code

57665

Product ID

57665-001_b0affb48-ca3f-46a7-8260-5a4819eb21d4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

pegademase bovine

Dosage form

INJECTION, SOLUTION

Route

INTRAMUSCULAR

Labeler

Leadiant Biosciences, Inc.

Application

NDA019818

Marketing category

NDA

Marketing start

2010-10-18

Marketing end

0000-00-00

Substance

PEGADEMASE BOVINE

Active strength

250 [iU]/mL

Pharmacologic classes

Adenosine Deaminase [CS],Bovine Intestinal Adenosine Deaminase [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record