ng End Date
1 NDC:62856-798-01 5 in 1 CARTON
1 1.5 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021372 05/28/2014
Labeler - Eisai Inc. (831600833)
Establishment
Name Address ID/FEI Business Operations
Helsinn Advanced Synthesis SA 481296960 API MANUFACTURE(62856-797, 62856-798)
Establishment
Name Address ID/FEI Business Operations
Helsinn Birex Pharmaceuticals Limited 985084409 PACK(62856-797, 62856-798)
Establishment
Name Address ID/FEI Business Operations
Oso BioPharmaceutical Manufacturing, LLC 826977121 MANUFACTURE(62856-797, 62856-798)
Establishment
Name Address ID/FEI Business Operations
Pierre Fabre Medicament Production 504638276 MANUFACTURE(62856-797, 62856-798) |