Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211280
Company: ELI LILLY AND CO
Company: ELI LILLY AND CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REYVOW | LASMIDITAN SUCCINATE | 50MG | TABLET;ORAL | Prescription | None | Yes | No |
| REYVOW | LASMIDITAN SUCCINATE | 100MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| REYVOW | LASMIDITAN SUCCINATE | 200MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/11/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211280s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211280Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211280Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/17/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211280s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211280Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2020 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211280s001lbl.pdf | |
| 07/17/2020 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211280s001lbl.pdf | |
| 07/17/2020 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211280s001lbl.pdf | |
| 10/11/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211280s000lbl.pdf |
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