Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204042
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INVOKANA CANAGLIFLOZIN 100MG TABLET;ORAL Prescription None Yes No
INVOKANA CANAGLIFLOZIN 300MG 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
03/29/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204042s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204042Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204042Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204042Orig1s026.pdf
08/17/2016 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s022ltr.pdf
05/20/2016 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf
02/01/2017 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204042Orig1s018ltr.pdf
06/16/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/20/2016 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf
12/04/2015 SUPPL-13 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s013ltr.pdf
03/08/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/28/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s011ltr.pdf
09/09/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf
03/03/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s005ltr.pdf
06/05/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/15/2014 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204042Orig1s002ltr.pdf
11/26/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf
02/01/2017 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s018lbl.pdf
08/17/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s022lbl.pdf
05/20/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf
05/20/2016 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf
03/28/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s011lbl.pdf
12/04/2015 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf
09/10/2015 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf
03/03/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s005lbl.pdf
05/15/2014 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf
05/15/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf
03/29/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204042s000lbl.pdf

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