FDA.report

Application 209241

Type
NDA
Sponsor
NEUROCRINE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 40MG BASEYesNo
002INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 80MG BASEYesYes
003INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 60MG BASEYesNo

NDC Listings For This Application

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

DocumentTitleSubmission typeSubmission no.Date
810530SUPPL 292025-02-06
810510SUPPL 292025-02-06
809670SUPPL 292025-02-06
805320SUPPL 282024-12-06
805140SUPPL 282024-12-05
752640SUPPL 262023-08-22
751460SUPPL 262023-08-21
725470SUPPL242022-11-02
714680SUPPL162022-06-28
671940SUPPL202021-04-28
671810SUPPL202021-04-27
626160SUPPL162020-04-21
625390SUPPL162020-04-10
593420SUPPL122019-08-05
593520SUPPL122019-07-16
553640SUPPL32018-08-30
552260SUPPL32018-08-20
486100ORIG12017-06-01
486090ORIG12017-06-01
479380ORIG12017-04-12
479370ORIG12017-04-12