PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68135-495-04 5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761052 04/27/2017
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761052 04/27/2017
LABELER - BIOMARIN PHARMACEUTICAL INC. (007004745)
ESTABLISHMENT
Name Address ID/FEI Business Operations
AndersonBrecon (UK) Ltd. 762771269 LABEL(68135-811, 68135-500, 68135-495) , PACK(68135-811, 68135-500, 68135-495)
ESTABLISHMENT
Name Address ID/FEI Business Operations
BioMarin International Limited 985066780 ANALYSIS(68135-811, 68135-500, 68135-500, 68135-495)
ESTABLISHMENT
Name Address ID/FEI Business Operations
BioMarin Pharmaceutical Inc. 010004135 ANALYSIS(68135-811, 68135-500, 68135-495) , MANUFACTURE(68135-811, 68135-500, 68135-495)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Piramal Pharma Solutions, Inc. 833246890 ANALYSIS(68135-811, 68135-500, 68135-495) , MANUFACTURE(68135-811, 68135-500, 68135-495)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Wickham Laboratories Ltd. 216813220 ANALYSIS(68135-811, 68135-500, 68135-495)
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