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Drugs@FDA: FDA-Approved Drugs

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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/28/2023 SUPPL-53 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021995Orig1s053lbl.pdf
06/21/2022 SUPPL-50 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf
06/21/2022 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf
12/04/2020 SUPPL-47 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021995s047lbl.pdf
08/12/2019 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s045lbl.pdf
07/01/2019 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf
02/09/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf
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 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf
04/14/2011 SUPPL-17 REMS-Modified 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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