Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208573
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENCLEXTA | VENETOCLAX | 10MG | TABLET;ORAL | Prescription | None | Yes | No |
| VENCLEXTA | VENETOCLAX | 50MG | TABLET;ORAL | Prescription | None | Yes | No |
| VENCLEXTA | VENETOCLAX | 100MG | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/11/2016 | 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/2016/208573s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208573Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208573Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208573Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2022 | SUPPL-27 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208573s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208573Orig1s027ltr.pdf | |
| 10/22/2021 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208573Orig1s026ltr.pdf | |
| 10/04/2021 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208573Orig1s024ltr.pdf | |
| 11/19/2020 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208573Orig1s023ltr.pdf | |
| 10/16/2020 | SUPPL-21 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208573Orig1s020, s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208573Orig1s020, s021.pdf | |
| 10/16/2020 | SUPPL-20 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208573Orig1s020, s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208573Orig1s020, s021.pdf | |
| 05/29/2020 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208573Orig1s018replacementltr.pdf | |
| 06/12/2020 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573Orig1s017Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208573Orig1s017ltr.pdf | |
| 07/25/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208573Orig1s011,s014,s015ltr.pdf | |
| 07/25/2019 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208573Orig1s011,s014,s015ltr.pdf | |
| 05/15/2019 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208573Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208573Orig1s013TOC.cfm | |
| 07/25/2019 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208573Orig1s011,s014,s015ltr.pdf | |
| 09/07/2018 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573Orig1s007s010lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s007s010Ltr.pdf | |
| 11/21/2018 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s009ltr.pdf | |
| 09/07/2018 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573Orig1s007s010lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s007s010Ltr.pdf | |
| 06/08/2018 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s004s005ltr.pdf | |
| 06/08/2018 | SUPPL-4 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s004s005ltr.pdf | |
| 12/20/2017 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208573s003lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208573s027lbl.pdf | |
| 06/15/2022 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208573s027lbl.pdf | |
| 10/22/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s026lbl.pdf | |
| 10/04/2021 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s024lbl.pdf | |
| 11/19/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s023lbl.pdf | |
| 10/16/2020 | SUPPL-21 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s020s021lbl.pdf | |
| 10/16/2020 | SUPPL-20 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s020s021lbl.pdf | |
| 06/12/2020 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573Orig1s017Lbl.pdf | |
| 05/29/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208573s018lbl.pdf | |
| 07/25/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf | |
| 07/25/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf | |
| 07/25/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf | |
| 05/15/2019 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s013lbl.pdf | |
| 11/21/2018 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s009lbl.pdf | |
| 09/07/2018 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573Orig1s007s010lblrpl.pdf | |
| 09/07/2018 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573Orig1s007s010lblrpl.pdf | |
| 06/08/2018 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf | |
| 06/08/2018 | SUPPL-4 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf | |
| 12/20/2017 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208573s003lbl.pdf | |
| 04/11/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf |