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PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12496-0589-2 1 in 1 POUCH
1 NDC:12496-0589-5 1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/19/2018
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/19/2018
PERSERIS
risperidone kit
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12496-0120
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12496-0120-1 1 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 11/19/2018
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 1.2 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
PERSERIS
risperidone powder
PRODUCT INFORMATION
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Risperidone (UNII: L6UH7ZF8HC) (Risperidone - UNII:L6UH7ZF8HC) Risperidone 120 mg in 0.8 mL
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 POUCH
1 1.2 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/19/2018
Part 2 of 2
DELIVERY SYSTEM
poly(dl-lactic-co-glycolic acid), (50:50; 46000 mw), methylpyrrolidone liquid
PRODUCT INFORMATION
Item Code (Source) NDC:12496-0776
Route of Administration SUBCUTANEOUS
INACTIVE INGREDIENTS
Ingredient Name Strength
Poly(DL-lactic-co-glycolic acid), (50:50; 46000 MW) (UNII: LQ35R50VR1)
Methylpyrrolidone (UNII: JR9CE63FPM)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12496-0776-2 1 in 1 POUCH
1 NDC:12496-0776-5 1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/19/2018
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/19/2018
LABELER - INDIVIOR INC. (797408549)
ESTABLISHMENT
Name Address ID/FEI Business Operations
AMRI Burlington 556991748 ANALYSIS(12496-0090, 12496-0120) , MANUF |
