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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209241
Company: NEUROCRINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INGREZZA VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE;ORAL Prescription AB Yes No
INGREZZA VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE;ORAL Prescription AB Yes Yes
INGREZZA VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/11/2017 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209241Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/22/2024 SUPPL-28 Labeling-Container/Carton Labels

Label is not available on this site.

08/18/2023 SUPPL-26 Efficacy Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209241Orig1s026ltr.pdf
08/11/2022 SUPPL-24 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209241Orig1s024lbl.pdf
04/23/2021 SUPPL-20 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209241Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209241Orig1s020ltr.pdf
04/09/2020 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209241s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209241Orig1s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/209241Orig1s016.pdf
07/15/2019 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209241s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209241Orig1s012Replacementltr.pdf
01/10/2019 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

08/10/2018 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209241s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209241Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/18/2023 SUPPL-26 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s026lbl.pdf
08/11/2022 SUPPL-24 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209241Orig1s024lbl.pdf
04/23/2021 SUPPL-20 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209241Orig1s020lbl.pdf
04/09/2020 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209241s016lbl.pdf
07/15/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209241s012lbl.pdf
08/10/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209241s003lbl.pdf
04/11/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf

INGREZZA

CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INGREZZA VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE;ORAL Prescription Yes AB 209241 NEUROCRINE
VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 216064 LUPIN LTD
VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 216137 ZYDUS

CAPSULE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INGREZZA VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE;ORAL Prescription Yes AB 209241 NEUROCRINE
VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 216064 LUPIN LTD
VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 216137 ZYDUS

CAPSULE;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INGREZZA VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE;ORAL Prescription Yes AB 209241 NEUROCRINE
VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 216137 ZYDUS
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