Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205879
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INVOKAMET XR CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
INVOKAMET XR CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
INVOKAMET XR CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
INVOKAMET XR CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150MG;1GM TABLET, EXTENDED RELEASE;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
09/20/2016 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205879s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205879Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205879Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205879s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204353Orig1s031,205879Orig1s009ltr.pdf
10/29/2018 SUPPL-7 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-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205879Orig1s006ltr.pdf
07/25/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205879Orig1s005ltr.pdf
01/02/2018 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205879s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205879s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2018 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf
10/26/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205879s009lbl.pdf
01/02/2018 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205879s002lbl.pdf
08/11/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s006lbl.pdf
07/25/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s005lbl.pdf
09/20/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205879s000lbl.pdf

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