Application 215870
- Type
- NDA
- Sponsor
- EXELA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | SOLUTION;INTRAVENOUS | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No |
| 002 | FENTANYL CITRATE | FENTANYL CITRATE | SOLUTION;INTRAVENOUS | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215870-001 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | |
| N215870-002 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215870-001 | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215870-002 | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215870-001 | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215870-002 | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215870-001 | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215870-002 | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215870-001 | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215870-002 | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-02-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215870-001 | FENTANYL CITRATE | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-02-08 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215870-002 | FENTANYL CITRATE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-02-08 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215870-001 | FENTANYL CITRATE | EQ 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 | RLD | 2023-02-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215870-002 | FENTANYL CITRATE | EQ 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 | RLD | 2023-02-08 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | bfa8018a-4cbc-434b-e09e-782872b0340a | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| FENTANYL CITRATE | FENTANYL CITRATE | Hospira, Inc. | 1ed25b2c-334e-4021-ada1-3396f07630dc | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Hikma Pharmaceuticals USA Inc. | ce5db1c2-feb1-4ad2-847a-d02e865bd47e | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Civica, Inc. | aacf276b-e133-4199-ad3f-67b894744c04 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Phlow Corp. | 58dcd3f7-e3d8-4929-a186-8f680a51ff11 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Hikma Pharmaceuticals USA Inc. | c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Fresenius Kabi USA, LLC | 0c10e465-4117-48ba-a454-23ccb7a3fcc7 | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Fresenius Kabi USA, LLC | 38d0c14a-a0c1-44cc-a939-0304eb8037d6 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.