NDC 63713-050

EVARREST

Fibrinogen Human And Human Thrombin

EVARREST is a Topical Patch in the Plasma Derivative category. It is labeled and distributed by Ethicon, Inc.. The primary component is Fibrinogen Human; Human Thrombin.

Product ID63713-050_3bce3aef-3db1-4a3c-94fe-943f878e1dc7
NDC63713-050
Product TypePlasma Derivative
Proprietary NameEVARREST
Generic NameFibrinogen Human And Human Thrombin
Dosage FormPatch
Route of AdministrationTOPICAL
Marketing Start Date2013-03-01
Marketing CategoryBLA / BLA
Application NumberBLA125392
Labeler NameEthicon, Inc.
Substance NameFIBRINOGEN HUMAN; HUMAN THROMBIN
Active Ingredient Strength9 mg/cm2; [iU]/cm2
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 Through2024-12-31

Packaging

NDC 63713-050-24

2 POUCH in 1 CARTON (63713-050-24) > 1 TRAY in 1 POUCH (63713-050-25) > 52 cm2 in 1 TRAY
Marketing Start Date2013-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63713-050-24 [63713005024]

EVARREST PATCH
Marketing CategoryBLA
Application NumberBLA125392
Product TypePLASMA DERIVATIVE
Marketing Start Date2013-03-01

NDC 63713-050-25 [63713005025]

EVARREST PATCH
Marketing CategoryBLA
Application NumberBLA125392
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2013-03-01

NDC 63713-050-44 [63713005044]

EVARREST PATCH
Marketing CategoryBLA
Application NumberBLA125392
Product TypePLASMA DERIVATIVE
Marketing Start Date2013-03-01
Marketing End Date2020-02-04

Drug Details

Active Ingredients

IngredientStrength
FIBRINOGEN HUMAN8.6 mg/cm2

Pharmacological Class

  • 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]

Trademark Results [EVARREST]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVARREST
EVARREST
85758636 4585142 Live/Registered
JOHNSON & JOHNSON
2012-10-19
EVARREST
EVARREST
77671639 4225953 Live/Registered
Johnson & Johnson
2009-02-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.