FDA.reportPublic FDA data

Application 209241

Type
NDA
Sponsor
NEUROCRINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 40MG BASEYesNo
002INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 80MG BASEYesYes
003INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 60MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70370-1040INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-1040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1048INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-1048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1060INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1060INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1060INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81053SUPPL 2025-02-06
81051SUPPL 2025-02-06
80967SUPPL 2025-02-06
80532SUPPL 2024-12-06
80514SUPPL 2024-12-05
75264SUPPL 2023-08-22
75146SUPPL 2023-08-21
72547SUPPL2022-11-02
71468SUPPL2022-06-28
67194SUPPL2021-04-28
67181SUPPL2021-04-27
62616SUPPL2020-04-21
62539SUPPL2020-04-10
59342SUPPL2019-08-05
59352SUPPL2019-07-16
55364SUPPL2018-08-30
55226SUPPL2018-08-20
48610ORIG2017-06-01
48609ORIG2017-06-01
47938ORIG2017-04-12
47937ORIG2017-04-12