Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209805
Company: MSD SUB MERCK
Company: MSD SUB MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STEGLUJAN | ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE | 5MG;EQ 100MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
STEGLUJAN | ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE | 15MG;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 |
---|---|---|---|---|---|---|---|
12/19/2017 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209805s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209805Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209803,209805,209806Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209805s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209803Orig1s007;209805Orig1s016;209806Orig1s010ltr.pdf | |
10/13/2022 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209803Orig1s006,209805Orig1s012,209806Orig1s009ltr.pdf | |
06/21/2022 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209805Orig1s011ltr.pdf | |
03/02/2022 | SUPPL-10 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209805Orig1s010, 209806Orig1s008ltr.pdf | |
09/17/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209805s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209803Orig1s004; 209805Orig1s008; 209806Orig1s006ltr.pdf | |
01/24/2020 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209805s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209803Orig1s002,209805Orig1s006,209806Orig1s002ltr.pdf | |
07/01/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209805s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209805Orig1s005ltr.pdf | |
10/26/2018 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209805Orig1s004Ltr.pdf | |
03/06/2018 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209805Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209805s016lbl.pdf | |
09/12/2023 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209805s016lbl.pdf | |
10/13/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s012lbl.pdf | |
06/21/2022 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s011lbl.pdf | |
03/02/2022 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s010lbl.pdf | |
09/17/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209805s008lbl.pdf | |
01/24/2020 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209805s006lbl.pdf | |
01/24/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209805s006lbl.pdf | |
07/01/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209805s005lbl.pdf | |
10/26/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf | |
10/26/2018 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf | |
03/06/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf | |
12/19/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209805s000lbl.pdf |