Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218590
Company: KNOA PHARMA
Company: KNOA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZURNAI (AUTOINJECTOR) | NALMEFENE HYDROCHLORIDE | EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 08/07/2024 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218590s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218590Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218590Orig1s000TOC.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/07/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218590s000lbl.pdf |