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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218390

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INGREZZA SPRINKLE (VALBENAZINE TOSYLATE)
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)
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)
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
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