Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202343
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/07/2011 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202343s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202343s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2014 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202343s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202343Orig1s011ltr.pdf
08/19/2013 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s010ltr.pdf
11/08/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/25/2013 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s008ltr.pdf
10/31/2012 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf
02/11/2013 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s006ltr.pdf
10/31/2012 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf
09/18/2012 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf
09/18/2012 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf
09/18/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/24/2014 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202343s011lbl.pdf
10/25/2013 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s008lbl.pdf
08/19/2013 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s010lbl.pdf
02/11/2013 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s006lbl.pdf
10/31/2012 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf
10/31/2012 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf
09/18/2012 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf
09/18/2012 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf
09/18/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf
10/07/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202343s000lbl.pdf

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