Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204353
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
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
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

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