Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200678
Company: ASTRAZENECA AB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 500MG;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/05/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200678s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678_kombiglyze_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2019 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004, 210874Orig1s001ltr.pdf
01/18/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf
01/18/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf
02/27/2017 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf
08/28/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf
02/09/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/05/2016 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf
05/24/2013 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200678Orig1s010ltr.pdf
11/08/2012 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/01/2012 SUPPL-7 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s007ltr.pdf
11/15/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200678s005ltr.pdf
03/07/2012 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf
03/07/2012 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf
05/15/2013 SUPPL-2 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
07/01/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf
02/27/2017 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf
01/18/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf
01/18/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf
04/05/2016 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf
08/28/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf
05/24/2013 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf
03/07/2012 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf
03/07/2012 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf
11/15/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf
11/05/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf

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