NDC 0338-9637

ARTISS Fibrin Sealant

Fibrinogen Human, Human Thrombin

ARTISS Fibrin Sealant is a Topical Solution in the Plasma Derivative category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Fibrinogen Human; Human Thrombin.

Product ID0338-9637_74bb54d7-5945-4f63-aedb-69fd113d5409
NDC0338-9637
Product TypePlasma Derivative
Proprietary NameARTISS Fibrin Sealant
Generic NameFibrinogen Human, Human Thrombin
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2008-03-19
Marketing CategoryBLA /
Application NumberBLA125266
Labeler NameBaxter Healthcare Corporation
Substance NameFIBRINOGEN HUMAN; HUMAN THROMBIN
Active Ingredient Strength87 mg/mL; [iU]/mL
Pharm ClassesBlood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0338-9637-01

2 mL in 1 SYRINGE, PLASTIC (0338-9637-01)
Marketing Start Date2008-03-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ARTISS Fibrin Sealant" or generic name "Fibrinogen Human, Human Thrombin"

NDCBrand NameGeneric Name
0338-8503ARTISSFibrinogen Human, Human Thrombin
0338-9637ARTISSFibrinogen Human, Human Thrombin
0338-9639ARTISSFibrinogen Human, Human Thrombin
0338-4210TISSEELfibrinogen human, human thrombin
0338-4211TISSEELfibrinogen human, human thrombin
0338-4212TISSEELfibrinogen human, human thrombin
0338-4301TISSEELfibrinogen human, human thrombin
0338-4302TISSEELfibrinogen human, human thrombin
0338-4303TISSEELfibrinogen human, human thrombin
0338-8402TISSEELfibrinogen human, human thrombin
0338-9560TISSEELfibrinogen human, human thrombin
0338-9564TISSEELfibrinogen human, human thrombin
0338-9568TISSEELfibrinogen human, human thrombin

Trademark Results [ARTISS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARTISS
ARTISS
78514937 3502970 Live/Registered
Baxter International Inc.
2004-11-10

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