Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022044
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JANUMET METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500MG;EQ 50MG BASE TABLET;ORAL Prescription None Yes No
JANUMET METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1GM;EQ 50MG 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
03/30/2007 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022044s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022044TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2017 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf
01/18/2017 SUPPL-40 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022044Orig1s039,s040ltr.pdf
01/18/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022044Orig1s039,s040ltr.pdf
08/28/2015 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf
04/27/2015 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf
06/12/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/18/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/11/2013 SUPPL-29 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022044Origs029ltr.pdf
06/28/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/07/2013 SUPPL-27 Labeling-Medication Guide, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022044Orig1s027ltr.pdf
10/18/2012 SUPPL-26 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022044Orig1s026ltr.pdf
03/24/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022044s022ltr.pdf
09/24/2010 SUPPL-18 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s014,s018ltr.pdf
04/14/2011 SUPPL-16 REMS-Modified, Labeling Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016(1)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016ltr.pdf
06/10/2011 SUPPL-15 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-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s014,s018ltr.pdf
02/26/2010 SUPPL-13 REMS-Proposal, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf
02/26/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf
12/28/2009 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022044s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022044s011ltr.pdf
02/26/2010 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf
10/20/2008 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s009ltr.pdf
05/01/2008 SUPPL-7 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s007ltr.pdf
01/02/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf
01/02/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf
02/26/2008 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s003, 004ltr.pdf
02/26/2008 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s003, s004ltr.pdf
01/02/2008 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf
10/11/2007 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

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-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s042lbl.pdf
01/18/2017 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf
01/18/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf
01/18/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf
08/28/2015 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s035lbl.pdf
04/27/2015 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s034lbl.pdf
09/11/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s029lbl.pdf
09/11/2013 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s029lbl.pdf
02/07/2013 SUPPL-27 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s027lbl.pdf
02/07/2013 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s027lbl.pdf
10/18/2012 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s026lbl.pdf
03/24/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s022lbl.pdf
04/14/2011 SUPPL-16 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf
04/14/2011 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf
04/14/2011 SUPPL-16 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf
04/14/2011 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf
09/24/2010 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf
09/24/2010 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf
02/26/2010 SUPPL-13 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf
02/26/2010 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf
02/26/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf
02/26/2010 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf
12/28/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022044s011lbl.pdf
02/26/2008 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf
02/26/2008 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf
01/02/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf
01/02/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf
01/02/2008 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf
03/30/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022044lbl.pdf

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