TachoSil

Product NDC

0944-8701

11-digit product format

009448701

Labeler code

0944

Product ID

0944-8701_e7ac607f-3b8c-4e7f-aaec-e9421b020e62

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

THROMBIN HUMAN and FIBRINOGEN

Dosage form

PATCH

Route

TOPICAL

Labeler

Baxalta US Inc.

Application

BLA125351

Marketing category

BLA

Marketing start

2010-04-05

Marketing end

2020-05-31

Substance

HUMAN THROMBIN; FIBRINOGEN HUMAN

Active strength

2 [USP'U]/1; mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record