Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220406
Company: AVYXA HOLDINGS
Company: AVYXA HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VYKOURA | LEUCOVORIN CALCIUM | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | None | Yes | Yes |
| VYKOURA | LEUCOVORIN CALCIUM | EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | None | Yes | Yes |
| VYKOURA | LEUCOVORIN CALCIUM | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 02/03/2026 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220406s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220406Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/03/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220406s000lbl.pdf |