Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761312
Company: CITIUS PHARMS
Company: CITIUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYMPHIR | DENILEUKIN DIFTITOX-CXDL | 300MCG | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/07/2024 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761312s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761312Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761312Orig1s000TOC.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/2024/761312s000lbl.pdf |