Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209241

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INGREZZA (VALBENAZINE TOSYLATE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: VALBENAZINE TOSYLATE
Proprietary Name: INGREZZA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N209241
Product Number: 001
Approval Date: Apr 11, 2017
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INGREZZA (VALBENAZINE TOSYLATE)
EQ 60MG BASE
Marketing Status: Prescription

Active Ingredient: VALBENAZINE TOSYLATE
Proprietary Name: INGREZZA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N209241
Product Number: 003
Approval Date: Apr 23, 2021
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INGREZZA (VALBENAZINE TOSYLATE)
EQ 80MG BASE
Marketing Status: Prescription

Active Ingredient: VALBENAZINE TOSYLATE
Proprietary Name: INGREZZA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N209241
Product Number: 002
Approval Date: Oct 4, 2017
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information