Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209803
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STEGLATRO | ERTUGLIFLOZIN | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
| STEGLATRO | ERTUGLIFLOZIN | 15MG | 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 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209803Orig1s000ltr.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 |
|---|---|---|---|---|---|
| 09/17/2021 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209803Orig1s004; 209805Orig1s008; 209806Orig1s006ltr.pdf | |
| 01/24/2020 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209803Orig1s002,209805Orig1s006,209806Orig1s002ltr.pdf | |
| 10/26/2018 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209803Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/17/2021 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf | |
| 01/24/2020 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf | |
| 01/24/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf | |
| 10/26/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf | |
| 10/26/2018 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf | |
| 12/19/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf |
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