FDA Approval for APHEXDA issued to BIOLINERX, LTD.
$BLRX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 217159
Company: BIOLINERX, LTD.
Company: BIOLINERX, LTD.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APHEXDA | MOTIXAFORTIDE | 62MG | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 09/08/2023 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |