Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021995
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JANUVIA SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET;ORAL Prescription None Yes No
JANUVIA SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET;ORAL Prescription None Yes No
JANUVIA SITAGLIPTIN PHOSPHATE EQ 100MG BASE 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
10/16/2006 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021995s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021995s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2017 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf
01/18/2017 SUPPL-38 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s038ltr.pdf
01/11/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/28/2015 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf
04/27/2015 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf
03/10/2015 SUPPL-32 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s032ltr.pdf
08/19/2013 SUPPL-29 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s029ltr.pdf
10/17/2013 SUPPL-28 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf
02/11/2013 SUPPL-27 Labeling-Container/Carton Labels, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s027ltr_replacement.pdf
12/07/2012 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/18/2012 SUPPL-25 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995Orig1s025ltr.pdf
03/24/2012 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995s023ltr.pdf
02/27/2012 SUPPL-19 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf
09/24/2010 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf
04/14/2011 SUPPL-17 REMS-Modified, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021995s017ltr.pdf
06/10/2011 SUPPL-16 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
09/24/2010 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf
02/26/2010 SUPPL-14 Labeling-Medication Guide, REMS-Proposal Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021995Orig1s014.pdf
12/28/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021995s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021995Orig1s013.pdf
02/26/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf
02/26/2010 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf
02/26/2010 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf
10/20/2008 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s009ltr.pdf
07/22/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s007ltr.pdf
10/12/2007 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf
10/12/2007 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf
10/12/2007 SUPPL-3 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf
10/12/2007 SUPPL-2 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf
07/22/2008 SUPPL-1

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf
01/18/2017 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf
08/28/2015 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf
04/27/2015 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf
03/10/2015 SUPPL-32 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf
10/17/2013 SUPPL-28 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf
08/19/2013 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf
02/11/2013 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf
02/11/2013 SUPPL-27 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf
10/18/2012 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf
03/24/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf
02/27/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf
04/14/2011 SUPPL-17 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf
04/14/2011 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf
09/24/2010 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf
09/24/2010 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf
02/26/2010 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf
02/26/2010 SUPPL-14 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf
02/26/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf
02/26/2010 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf
02/26/2010 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf
12/28/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf
07/22/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf
10/16/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf

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