FDA — authorised 8 August 2014
- Application: NDA204353
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVOKAMET
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Invokana Pill in United States
FDA authorised Invokana Pill on 8 August 2014
Marketing authorisations
FDA — authorised 20 September 2016
- Application: NDA205879
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVOKAMET XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2026
- Application: ANDA210449
- Marketing authorisation holder: APOTEX
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2026
- Application: ANDA210386
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210297
- Marketing authorisation holder: SANDOZ INC
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210451
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210503
- Marketing authorisation holder: LAURUS LABS LTD
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210541
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210542
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Invokana Pill in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Diabetes approved in United States
Frequently asked questions
Is Invokana Pill approved in United States?
Yes. FDA authorised it on 8 August 2014; FDA authorised it on 20 September 2016; FDA authorised it on 14 April 2026.
Who is the marketing authorisation holder for Invokana Pill in United States?
JANSSEN PHARMS holds the US marketing authorisation.