Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022044
Company: MSD SUB MERCK
Company: MSD SUB MERCK
| 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 |
|---|---|---|---|---|---|
| 06/21/2022 | SUPPL-52 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021995Orig1s050, 022044Orig1s052, 202270Orig1s026ltr.pdf | |
| 11/04/2021 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022044Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022044Orig1s051ltr.pdf | |
| 12/04/2020 | SUPPL-48 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022044s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021995Orig1s047; 022044Orig1s048; 202270Orig1s022ltr.pdf | |
| 07/01/2019 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s046, 022044Orig1s047, 202270Orig1s020ltr.pdf | |
| 08/12/2019 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022044s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s045, 202270Orig1s019, 022044Orig1s046.ltr.pdf | |
| 02/09/2018 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022044s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf | |
| 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/2011/022044s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016(1)ltr.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 |
|---|---|---|---|---|---|
| 06/21/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf | |
| 06/21/2022 | SUPPL-52 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf | |
| 11/04/2021 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022044Orig1s051lbl.pdf | |
| 12/04/2020 | SUPPL-48 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022044s048lbl.pdf | |
| 08/12/2019 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022044s046lbl.pdf | |
| 07/01/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022044s047lbl.pdf | |
| 02/09/2018 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022044s043lbl.pdf | |
| 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 |