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Last Updated: August 4, 2020

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Suppliers and packages for generic ingredient: RISPERIDONE

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RISPERIDONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Indivior Inc PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655 NDA Indivior Inc. 12496-0090-1 1 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0589-2) > 1 mL in 1 SYRINGE (12496-0589-5)
Indivior Inc PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655 NDA Indivior Inc. 12496-0090-9 1 KIT in 1 CARTON (12496-0090-9) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0589-2) > 1 mL in 1 SYRINGE (12496-0589-5)
Indivior Inc PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655 NDA Indivior Inc. 12496-0120-1 1 KIT in 1 CARTON (12496-0120-1) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0776-2) > 1 mL in 1 SYRINGE (12496-0776-5)
Indivior Inc PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655 NDA Indivior Inc. 12496-0120-9 1 KIT in 1 CARTON (12496-0120-9) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0776-2) > 1 mL in 1 SYRINGE (12496-0776-5)
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-306-11 1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-307-11 1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-308-11 1 KIT in 1 BOX (50458-308-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package

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