Product Details for NDA 218390
INGREZZA SPRINKLE (VALBENAZINE TOSYLATE)
EQ 40MG BASE
Marketing Status: Prescription
EQ 60MG BASE
Marketing Status: Prescription
EQ 80MG BASE
Marketing Status: Prescription
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: VALBENAZINE TOSYLATE
Proprietary Name: INGREZZA SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N218390
Product Number: 001
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status: Prescription
Patent and Exclusivity Information
INGREZZA SPRINKLE (VALBENAZINE TOSYLATE)
Proprietary Name: INGREZZA SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N218390
Product Number: 001
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 60MG BASE
Marketing Status: Prescription
Active Ingredient: VALBENAZINE TOSYLATE
Proprietary Name: INGREZZA SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N218390
Product Number: 002
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status: Prescription
Patent and Exclusivity Information
INGREZZA SPRINKLE (VALBENAZINE TOSYLATE)
Proprietary Name: INGREZZA SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N218390
Product Number: 002
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 80MG BASE
Marketing Status: Prescription
Active Ingredient: VALBENAZINE TOSYLATE
Proprietary Name: INGREZZA SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N218390
Product Number: 003
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: INGREZZA SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N218390
Product Number: 003
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status: Prescription
Patent and Exclusivity Information