Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218578
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERDAFITINIB | ERDAFITINIB | TABLET | None (Tentative Approval) | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 02/02/2026 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218578Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218578Orig1s000ltr.pdf |