/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795 01/02/2003
ENBREL
etanercept solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58406-455
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETANERCEPT (ETANERCEPT) ETANERCEPT 25 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE HYDROCHLORIDE 0.025 mmol in 1 mL
SODIUM CHLORIDE 0.1 mmol in 1 mL
SODIUM PHOSPHATE 0.025 mmol in 1 mL
SUCROSE 10 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 58406-455-04 4 SYRINGE In 1 CARTON contains a SYRINGE (58406-455-01)
1 58406-455-01 0.5 mL In 1 SYRINGE This package is contained within the CARTON (58406-455-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795 11/10/2005
Labeler - Immunex Corp (028134799)
Registrant - Amgen, Inc (039976196)
Establishment
Name Address ID/FEI Operations
Immunex Rhode Island Corporation 085509730 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Amgen, Inc 039976196 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH and Co. KG 340700520 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Amgen Manufacturing Ltd 785800020 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
DSM PHARMACEUTICALS INC 076301910 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma 174350868 MANUFACTURE
Establishment
Name Address ID/FEI Operations
BAXTER PHARMACEUTICALS SOLUTIONS LLC 604719430 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
VETTER PHARMA FERTIGUNG GMBH AND CO KG 344217323 MANUFACTURE
Establishment
Name Address ID/FEI Operations
VETTER PHARMA FERTIGUNG GMBH AND CO KG 316126754 ANALYSIS
Establishment
Name Address ID/FEI Operations
VETTER PHARMA FERTIGUNG GMBH AND CO KG 344069922 MANUFACTURE, ANALYSIS
Revised: 10/2009 Immunex Corp |
