For type 2 diabetes mellitus. NDA 204353, held by Janssen Pharms. Canagliflozin; Metformin Hydrochloride.
As of Nov 14, 2026, NDA 204353 (Invokamet), held by Janssen Pharms, was first approved by FDA on Aug 8, 2014, with 27 approved supplements and 0 published complete response letters.
INVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR
| Dec 18, 2024 | Supplement 46Efficacy (new indication or use) · Priority review | Approved | |
| Aug 18, 2020 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2020 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Oct 29, 2018 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2016 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 10, 2015 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2014 | Original applicationNew combination · Standard review | Approved |
| Invokamet50MG;500MG · tablet;oral | Canagliflozin; Metformin Hydrochloride | RxReference drug |
| Invokamet50MG;1GM · tablet;oral | Canagliflozin; Metformin Hydrochloride | RxReference drug |
| Invokamet150MG;500MG · tablet;oral | Canagliflozin; Metformin Hydrochloride | RxReference drug |
| Invokamet150MG;1GM · tablet;oral | Canagliflozin; Metformin Hydrochloride | RxReference drug |
| Aug 11, 2026 | Supplement 49Labeling | Approved | |
| Aug 11, 2026 | Supplement 48Labeling · Standard review | Approved | |
| Dec 18, 2024 | Supplement 46Efficacy (new indication or use) · Priority review | Approved | |
| Aug 23, 2024 | Supplement 45Labeling · Standard review | Approved | |
| Jan 19, 2024 | Supplement 43Labeling · Standard review | Approved | |
| Jul 5, 2023 | Supplement 42Labeling · Standard review | Approved | |
| Oct 13, 2022 | Supplement 41Labeling | Approved | |
| Aug 18, 2020 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2020 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jan 24, 2020 | Supplement 36Labeling | Approved | |
| Oct 29, 2018 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Oct 26, 2018 | Supplement 31Labeling | Approved | |
| Aug 11, 2017 | Supplement 24Labeling · Standard review | Approved | |
| Jul 25, 2017 | Supplement 23Labeling | Approved | |
| Feb 1, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2016 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Aug 17, 2016 | Supplement 20Labeling | Approved | |
| May 20, 2016 | Supplement 15Labeling | Approved | |
| May 20, 2016 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Apr 14, 2016 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Mar 28, 2016 | Supplement 10Labeling · Standard review | Approved | |
| Mar 17, 2016 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2015 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2015 | Supplement 12Labeling | Approved | |
| Sep 10, 2015 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 8, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 3, 2015 | Supplement 2Labeling · Standard review | Approved | |
| Aug 8, 2014 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
