Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218037
Company: ALEXION PHARMS INC
Company: ALEXION PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOYDEYA | DANICOPAN | 50MG | TABLET;ORAL | Prescription | None | Yes | No |
| VOYDEYA | DANICOPAN | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/2024 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218037Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218037Orig1s000TOC.cfm |