LE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA208845 10/06/2017
Part 2 of 2
DILUENT
diluent injection, solution
Product Information
Item Code (Source) NDC:70801-002
Route of Administration INTRA-ARTICULAR
Inactive Ingredients
Ingredient Name
Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:70801-002-01 1 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2
NDC:70801-002-02 1 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA208845 10/06/2017
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA208845 10/06/2017
Labeler - Flexion Therapeutics, Inc. (829859425)
Establishment
Name
Addess
ID/FEI
Business Operations
Packaging Coordinators, LLC (PCI) 078525133 label(70801-003)
Establishment
Name
Addess
ID/FEI
Business Operations
Cook Pharmica LLC 172209277 manufacture(70801-003)
Establishment
Name
Address
ID/FEI
Business Operations
Synergy Health Sterilisation UK Ltd 226067312 sterilize(70801-003)
Establishment
Name
Address
ID/FEI
Business Operations
Patheon UK Limited 237710418 manufacture(70801-003)
Establishment
Name
Address
ID/FEI
Business Operations
Farmabios S.p.A. 428680078 api manufacture(70801-003)
