3 NDC:54092-606-07 5 in 1 POUCH
3 0.2 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208073 07/11/2016
Labeler - Shire US Manufacturing Inc. (964907406)
Establishment
Name Address ID/FEI Business Operations
The Ritedose Corporation (TRC) 837769546 MANUFACTURE(54092-606) , ANALYSIS(54092-606) , PACK(54092-606) , LABEL(54092-606)
Establishment
Name Address ID/FEI Business Operations
AMRI Rensselaer, Inc. 124193793 API MANUFACTURE(54092-606) , ANALYSIS(54092-606) , PACK(54092-606)
Establishment
Name Address ID/FEI Business Operations
Sharp Corporation 143696495 LABEL(54092-606) , PACK(54092-606) |
