Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209241
Company: NEUROCRINE
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 |