Application 215870

Type: NDA
Sponsor: EXELA PHARMA

Application Products#

Product, Drug, Ingredient table
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EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No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EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-02-08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CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-02-08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.

Product history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	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CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215870-001	FENTANYL CITRATE	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215870-002	FENTANYL CITRATE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-08	`ea1830bbd6c7…`
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…`

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.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FENTANYL CITRATE generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	ce5db1c2-feb1-4ad2-847a-d02e865bd47e	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	bfa8018a-4cbc-434b-e09e-782872b0340a	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Teva Pharmaceuticals USA, Inc.	78221eab-66fd-4cd8-9c81-af52eb83671c	2026-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Civica, Inc.	aacf276b-e133-4199-ad3f-67b894744c04	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Phlow Corp.	58dcd3f7-e3d8-4929-a186-8f680a51ff11	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	0c10e465-4117-48ba-a454-23ccb7a3fcc7	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	38d0c14a-a0c1-44cc-a939-0304eb8037d6	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84633	SUPPL	2026-01-05
84587	SUPPL	2025-12-29
77063	SUPPL	2023-12-19
76975	SUPPL	2023-12-19
75518	ORIG	2023-09-20
73437	ORIG	2023-02-09
73429	ORIG	2023-02-09