ARTISS

Product NDC

0944-8503

11-digit product format

009448503

Labeler code

0944

Product ID

0944-8503_d24dc76a-fdfd-45cc-be76-310843afb46d

Type

PLASMA DERIVATIVE

Nonproprietary name

Fibrinogen Human Thrombin Human

Dosage form

SOLUTION

Route

TOPICAL

Labeler

Baxalta US Inc.

Application

BLA125266

Marketing category

BLA

Marketing start

2009-03-19

Marketing end

2019-06-30

Substance

FIBRINOGEN HUMAN; HUMAN THROMBIN

Active strength

90 mg/mL; [iU]/mL

Pharmacologic classes

Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record