Application 022510

Type: NDA
Sponsor: SENTYNL THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABSTRAL	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.1MG BASE	Yes	No
002	ABSTRAL	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.2MG BASE	Yes	No
003	ABSTRAL	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.3MG BASE	Yes	No
004	ABSTRAL	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.4MG BASE	Yes	No
005	ABSTRAL	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.6MG BASE	Yes	No
006	ABSTRAL	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.8MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022510-001	ABSTRAL	FENTANYL CITRATE	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-002	ABSTRAL	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-003	ABSTRAL	FENTANYL CITRATE	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-004	ABSTRAL	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-005	ABSTRAL	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-006	ABSTRAL	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N022510-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022510-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-006	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022510-001	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-001	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-001	7910132	2019-09-24	U-767	Drug product	2011-04-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-002	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-002	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-002	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-003	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-003	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-003	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-004	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-004	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-004	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-005	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-005	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-005	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-006	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-006	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-006	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022510-001	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-001	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-001	7910132	2019-09-24	U-767	Drug product	2011-04-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-002	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-002	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-002	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-003	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-003	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-003	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-004	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-004	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-004	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-005	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-005	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-005	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-006	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-006	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-006	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022510-001	6759059	2019-09-24	U-767	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-001	6761910	2019-09-24	U-767	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-001	7910132	2019-09-24	U-767	Drug product	2011-04-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-002	6759059	2019-09-24	U-767	Drug product		`b00525d2431f…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: FENTANYL CITRATE
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 generic name: FENTANYL CITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42358-100	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-100	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-100	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-200	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-200	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-200	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-300	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-300	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-400	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-400	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-400	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-600	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-600	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-600	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-800	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-800	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42358-800	Abstral	fentanyl citrate	Sentynl Therapeutics, Inc.	NDA	Current
42747-221	Abstral	fentanyl	ProStrakan, Inc.	NDA	Current
42747-222	Abstral	fentanyl	ProStrakan, Inc.	NDA	Current
42747-223	Abstral	fentanyl	ProStrakan, Inc.	NDA	Current
42747-224	Abstral	fentanyl	ProStrakan, Inc.	NDA	Current
42747-226	Abstral	fentanyl	ProStrakan, Inc.	NDA	Current
42747-228	Abstral	fentanyl	ProStrakan, Inc.	NDA	Current
57881-331	Abstral	fentanyl citrate	Galena Biopharma, Inc.	NDA	Current
57881-332	Abstral	fentanyl citrate	Galena Biopharma, Inc.	NDA	Current
57881-333	Abstral	fentanyl citrate	Galena Biopharma, Inc.	NDA	Current
57881-334	Abstral	fentanyl citrate	Galena Biopharma, Inc.	NDA	Current
57881-336	Abstral	fentanyl citrate	Galena Biopharma, Inc.	NDA	Current
57881-338	Abstral	fentanyl citrate	Galena Biopharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60494	SUPPL	2019-10-09
60493	SUPPL	2019-10-09
60445	SUPPL	2019-10-09
49714	SUPPL	2017-09-11
46381	SUPPL	2016-12-21
46333	SUPPL	2016-12-21
7471	SUPPL	2014-12-30
7470	SUPPL	2014-12-24
17658	SUPPL	2014-11-07
7468	SUPPL	2013-11-12
38776	SUPPL	2013-07-30
7469	SUPPL	2013-07-30
17657	SUPPL	2012-06-11
29796	SUPPL	2012-06-07
17656	SUPPL	2012-01-06
7467	SUPPL	2012-01-03
44765	ORIG	2011-11-02
42543	ORIG	2011-11-02
29795	ORIG	2011-01-14
24032	ORIG	2011-01-14
17655	ORIG	2011-01-10