NDA 215870, held by Exela Pharma. Fentanyl Citrate.
As of Nov 13, 2026, NDA 215870 (Fentanyl Citrate), held by Exela Pharma, was first approved by FDA on Feb 8, 2023, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fentanyl CitrateEQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Fentanyl Citrate | DiscontinuedReference drug |
| Fentanyl CitrateEQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Fentanyl Citrate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Feb 8, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
