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 | AB | Yes | No |
| JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 50MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/11/2026 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022044s058lbl.pdf | |
| 08/11/2026 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022044s058lbl.pdf | |
| 06/21/2022 | SUPPL-52 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf | |
| 06/21/2022 | SUPPL-52 | Labeling-Package Insert | 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 | 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 | |
| 04/14/2011 | SUPPL-16 | REMS-Modified | 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 |