Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204353
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 50MG;500MG | TABLET;ORAL | Prescription | None | Yes | No |
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 50MG;1GM | TABLET;ORAL | Prescription | None | Yes | No |
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 150MG;500MG | TABLET;ORAL | Prescription | None | Yes | No |
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 150MG;1GM | 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 |
|---|---|---|---|---|---|---|---|
| 08/08/2014 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204353Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/23/2024 | SUPPL-45 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204353s045,205879s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204353Orig1s045; 205879Orig1s022ltr.pdf | |
| 01/19/2024 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204353s043,205879s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204353Orig1s043; 205879Orig1s020ltr.pdf | |
| 07/05/2023 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204353Orig1s042;205879Orig1s019ltr.pdf | |
| 10/13/2022 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204353s041,205879s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204042Orig1s039,204353Orig1s041,205879Orig1s018ltr.pdf | |
| 08/18/2020 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204353Orig1s039,205879Orig1s017ltr.pdf | |
| 01/24/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s036,205879s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204042Orig1s036, 204353Orig1s036, 205879Orig1s014ltr.pdf | |
| 01/27/2020 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204353Orig1s033, 205879Orig1s011ltr.pdf | |
| 10/26/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204353Orig1s031,205879Orig1s009ltr.pdf | |
| 10/29/2018 | SUPPL-25 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204353Orig1s025,205879Orig1s007ltr.pdf | |
| 08/11/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s024ltr.pdf | |
| 07/25/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s023ltr.pdf | |
| 08/17/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s020ltr.pdf | |
| 11/23/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf | |
| 02/01/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s014ltr.pdf | |
| 12/04/2015 | SUPPL-12 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s012ltr.pdf | |
| 04/14/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2016 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s010ltr.pdf | |
| 03/17/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2016 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf | |
| 06/08/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s003ltr.pdf | |
| 03/03/2015 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/23/2024 | SUPPL-45 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204353s045,205879s022lbl.pdf | |
| 01/19/2024 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204353s043,205879s020lbl.pdf | |
| 07/05/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf | |
| 10/13/2022 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204353s041,205879s018lbl.pdf | |
| 08/18/2020 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf | |
| 01/27/2020 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf | |
| 01/24/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s036,205879s014lbl.pdf | |
| 10/29/2018 | SUPPL-25 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf | |
| 10/26/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s031lbl.pdf | |
| 08/11/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf | |
| 07/25/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s023lbl.pdf | |
| 02/01/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s014lbl.pdf | |
| 08/17/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s020lbl.pdf | |
| 05/20/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf | |
| 05/20/2016 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf | |
| 03/28/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf | |
| 12/04/2015 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s012lbl.pdf | |
| 09/10/2015 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf | |
| 03/03/2015 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s002lbl.pdf | |
| 08/08/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf |