Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022386
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRANDIMET METFORMIN HYDROCHLORIDE; REPAGLINIDE 500MG;1MG TABLET;ORAL Discontinued None Yes No
PRANDIMET METFORMIN HYDROCHLORIDE; REPAGLINIDE 500MG;2MG TABLET;ORAL Discontinued 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
06/23/2008 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022386s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386_prandimet_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022386Orig1s018ltr.pdf
12/08/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf
06/04/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/04/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/29/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/11/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/17/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/17/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/24/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s008ltr.pdf
03/01/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s007ltr.pdf
05/28/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022386s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf
04/05/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf
04/24/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf
03/01/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf
05/28/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf
06/23/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf

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