FDA.reportPublic FDA data

Application 210655

Type
NDA
Sponsor
INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERSERIS KITRISPERIDONEFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS90MGYesNo
002PERSERIS KITRISPERIDONEFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0090PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent
12496-0120PERSERISRisperidoneIndivior Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81089SUPPL 2025-02-06
80981SUPPL 2025-02-05
73004SUPPL2022-12-22
72915SUPPL2022-12-16
72558SUPPL2022-11-03
61804SUPPL2020-02-06
61789SUPPL2020-02-06
55125ORIG2018-08-07
55085ORIG2018-08-03
58697ORIG2018-07-27