Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215870
Company: EXELA PHARMA
Company: EXELA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/08/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215870s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215870Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215870Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215870s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215870Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215870s001lbl.pdf | |
| 02/08/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215870s000lbl.pdf |