Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220934
Company: ELI LILLY AND CO
Company: ELI LILLY AND CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOUNDAYO | ORFORGLIPRON CALCIUM | EQ 0.8MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| FOUNDAYO | ORFORGLIPRON CALCIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| FOUNDAYO | ORFORGLIPRON CALCIUM | EQ 5.5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| FOUNDAYO | ORFORGLIPRON CALCIUM | EQ 9MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| FOUNDAYO | ORFORGLIPRON CALCIUM | EQ 14.5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| FOUNDAYO | ORFORGLIPRON CALCIUM | EQ 17.2MG 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 |
|---|---|---|---|---|---|---|---|
| 04/01/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220934Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/01/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf |