Home Applications 215962 Application 215962
Type ANDA
Sponsor SANDOZ INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALBENAZINE VALBENAZINE CAPSULE;ORAL 40MG No No 002 VALBENAZINE VALBENAZINE CAPSULE;ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog .
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INGREZZA VALBENAZINE Neurocrine Biosciences, Inc. 4c970164-cafb-421f-9eb5-c226ef0a3417 2026-04-17 Boxed warning, Warnings, Adverse reactions Name fallback generic name: VALBENAZINE
Documents# Document, Submission type, Date table Document Submission type Date 73134 ORIG 2023-01-10