Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218171
Company: XCOVERY
Company: XCOVERY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENSACOVE | ENSARTINIB HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
ENSACOVE | ENSARTINIB HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
12/18/2024 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218171Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218171Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/18/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf |