IC ACID (UNII: PQ6CK8PD0R) 25 mg
SUCRALOSE (UNII: 96K6UQ3ZD4) 29.5 mg
POTASSIUM CITRATE (UNII: EE90ONI6FF) 162.5 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68135-482-11 30 in 1 CARTON
1 NDC:68135-482-10 1 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205065 05/27/2015
Labeler - BioMarin Pharmaceutical Inc. (007004745)
Establishment
Name Address ID/FEI Business Operations
AndersonBrecon Inc. 053217022 ANALYSIS(68135-482, 68135-301) , LABEL(68135-301, 68135-482) , MANUFACTURE(68135-482, 68135-301) , PACK(68135-301, 68135-482)
Establishment
Name Address ID/FEI Business Operations
BioMarin Pharmaceutical Inc. 010004135 ANALYSIS(68135-301, 68135-300, 68135-482)
Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions LLC 014904112 LABEL(68135-300) , PACK(68135-300)
Establishment
Name Address ID/FEI Business Operations
Excella GmbH 329809800 ANALYSIS(68135-300) , LABEL(68135-300) , MANUFACTURE(68135-300) , PACK(68135-300)
Establishment
Name Address ID/FEI Business Operations
Labor L+S AG 313710642 ANALYSIS(68135-300)
Establishment
Name Address ID/FEI Business Operations
SGS Institut Fresenius GmbH 317219699 ANALYSIS(68135-300)
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