Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204042
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVOKANA | CANAGLIFLOZIN | 100MG | TABLET;ORAL | Prescription | None | Yes | No |
| INVOKANA | CANAGLIFLOZIN | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204042s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204042Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/NDA/2013/204042Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/05/2023 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204042s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204042Orig1s040ltr.pdf | |
| 10/13/2022 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204042s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204042Orig1s039,204353Orig1s041,205879Orig1s018ltr.pdf | |
| 01/24/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204042Orig1s036, 204353Orig1s036, 205879Orig1s014ltr.pdf | |
| 08/18/2020 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204042Orig1s034ltr.pdf | |
| 09/27/2019 | SUPPL-32 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204042s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204042Orig1s032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/204042Orig1s032TOC.cfm | |
| 10/26/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204042s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204042Orig1s031ltr.pdf | |
| 10/29/2018 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204042s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204042Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204042Orig1s027.pdf | |
| 07/25/2017 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204042Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204042Orig1s026.pdf | |
| 08/17/2016 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s022ltr.pdf | |
| 05/20/2016 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf | |
| 02/01/2017 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204042Orig1s018ltr.pdf | |
| 06/16/2016 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2016 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf | |
| 12/04/2015 | SUPPL-13 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204042Orig1s013.pdf | |
| 03/08/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s011ltr.pdf | |
| 09/09/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf | |
| 03/03/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s005ltr.pdf | |
| 06/05/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2014 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204042Orig1s002ltr.pdf | |
| 11/26/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/05/2023 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204042s040lbl.pdf | |
| 10/13/2022 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204042s039lbl.pdf | |
| 08/18/2020 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s034lbl.pdf | |
| 01/24/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s036lbl.pdf | |
| 09/27/2019 | SUPPL-32 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204042s032lbl.pdf | |
| 10/29/2018 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204042s027lbl.pdf | |
| 10/26/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204042s031lbl.pdf | |
| 07/25/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf | |
| 02/01/2017 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s018lbl.pdf | |
| 08/17/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s022lbl.pdf | |
| 05/20/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf | |
| 05/20/2016 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf | |
| 03/28/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s011lbl.pdf | |
| 12/04/2015 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf | |
| 09/10/2015 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf | |
| 03/03/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s005lbl.pdf | |
| 05/15/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf | |
| 05/15/2014 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf | |
| 03/29/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204042s000lbl.pdf |