Application 021947

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTORA	FENTANYL CITRATE	TABLET;BUCCAL, SUBLINGUAL	EQ 0.1MG BASE	Yes	No
002	FENTORA	FENTANYL CITRATE	TABLET;BUCCAL, SUBLINGUAL	EQ 0.2MG BASE	Yes	No
003	FENTORA	FENTANYL CITRATE	TABLET;BUCCAL, SUBLINGUAL	EQ 0.4MG BASE	Yes	Yes
004	FENTORA	FENTANYL CITRATE	TABLET;BUCCAL, SUBLINGUAL	EQ 0.6MG BASE	Yes	No
005	FENTORA	FENTANYL CITRATE	TABLET;BUCCAL, SUBLINGUAL	EQ 0.8MG BASE	Yes	No
006	FENTORA	FENTANYL CITRATE	TABLET;BUCCAL, SUBLINGUAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021947-001	FENTORA	FENTANYL CITRATE	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25
N021947-002	FENTORA	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25
N021947-003	FENTORA	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25
N021947-004	FENTORA	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25
N021947-005	FENTORA	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25
N021947-006	FENTORA	FENTANYL CITRATE	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021947-001	7862832	2028-06-15	Drug product	2011-04-25
N021947-001	7862833	2028-06-15	Drug product	2011-04-25
N021947-002	7862832	2028-06-15	Drug product
N021947-002	7862833	2028-06-15	Drug product
N021947-003	7862832	2028-06-15	Drug product
N021947-003	7862833	2028-06-15	Drug product
N021947-004	7862832	2028-06-15	Drug product
N021947-004	7862833	2028-06-15	Drug product
N021947-005	7862832	2028-06-15	Drug product	2011-04-25
N021947-005	7862833	2028-06-15	Drug product	2011-04-25

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 · 246 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	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-005	FENTORA	EQ 0.8MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-006	FENTORA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-005	FENTORA	EQ 0.8MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-006	FENTORA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-005	FENTORA	EQ 0.8MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-006	FENTORA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-005	FENTORA	EQ 0.8MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-006	FENTORA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021947-005	FENTORA	EQ 0.8MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021947-006	FENTORA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021947-005	FENTORA	EQ 0.8MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021947-006	FENTORA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / BUCCAL, SUBLINGUAL	RLD	2007-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021947-001	FENTORA	EQ 0.1MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021947-002	FENTORA	EQ 0.2MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021947-003	FENTORA	EQ 0.4MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021947-004	FENTORA	EQ 0.6MG BASE	TABLET / BUCCAL, SUBLINGUAL	RLD	2006-09-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021947-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021947-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021947-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021947-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021947-005	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021947-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021947-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021947-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021947-004	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021947-005	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 833 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021947-001	7862832	2028-06-15	Drug product	2011-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-001	7862833	2028-06-15	Drug product	2011-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-002	7862832	2028-06-15	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-002	7862833	2028-06-15	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-003	7862832	2028-06-15	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-003	7862833	2028-06-15	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-004	7862832	2028-06-15	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-004	7862833	2028-06-15	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-005	7862832	2028-06-15	Drug product	2011-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021947-005	7862833	2028-06-15	Drug product	2011-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-001	7862832	2028-06-15	Drug product	2011-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-001	7862833	2028-06-15	Drug product	2011-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-002	7862832	2028-06-15	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-002	7862833	2028-06-15	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-003	7862832	2028-06-15	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-003	7862833	2028-06-15	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-004	7862832	2028-06-15	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-004	7862833	2028-06-15	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-005	7862832	2028-06-15	Drug product	2011-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021947-005	7862833	2028-06-15	Drug product	2011-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021947-001	7862832	2028-06-15	Drug product	2011-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-001	7862833	2028-06-15	Drug product	2011-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-002	7862832	2028-06-15	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-002	7862833	2028-06-15	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-003	7862832	2028-06-15	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-003	7862833	2028-06-15	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-004	7862832	2028-06-15	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-004	7862833	2028-06-15	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-005	7862832	2028-06-15	Drug product	2011-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021947-005	7862833	2028-06-15	Drug product	2011-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-001	7862832	2028-06-15	Drug product	2011-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-001	7862833	2028-06-15	Drug product	2011-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-002	7862832	2028-06-15	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-002	7862833	2028-06-15	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-003	7862832	2028-06-15	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-003	7862833	2028-06-15	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-004	7862832	2028-06-15	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-004	7862833	2028-06-15	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-005	7862832	2028-06-15	Drug product	2011-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021947-005	7862833	2028-06-15	Drug product	2011-04-25	`fd3edfee7708…`

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 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	Hospira, Inc.	bfa8018a-4cbc-434b-e09e-782872b0340a	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 65 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-634	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-634	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-634	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-634	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-635	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-635	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-635	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-635	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-636	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-636	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-636	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-636	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-637	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-637	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-637	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-637	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-638	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-638	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-638	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
51862-638	Fentanyl Buccal	Fentanyl Citrate	Mayne Pharma	NDA AUTHORIZED GENERIC	Current
63459-541	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-541	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-542	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-544	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-546	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, LLC	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current
63459-548	FENTORA	Fentanyl	Cephalon, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84688	SUPPL	2026-01-06
84604	SUPPL	2025-12-31
79502	SUPPL	2024-08-29
77006	SUPPL	2023-12-19
76918	SUPPL	2023-12-18
76917	SUPPL	2023-12-18
72848	SUPPL	2022-12-09
72708	SUPPL	2022-11-25
72679	SUPPL	2022-11-23
72678	SUPPL	2022-11-23
71845	SUPPL	2022-08-18
69494	SUPPL	2021-12-07
66599	SUPPL	2021-03-08
66598	SUPPL	2021-03-08
66554	SUPPL	2021-03-05
65768	SUPPL	2020-12-28
60490	SUPPL	2019-10-09
60489	SUPPL	2019-10-09
60440	SUPPL	2019-10-09
49712	SUPPL	2017-09-11
48027	SUPPL	2017-04-14
47996	SUPPL	2017-04-12
46349	SUPPL	2016-12-21
46348	SUPPL	2016-12-21
46294	SUPPL	2016-12-20
46293	SUPPL	2016-12-20
28909	SUPPL	2014-12-30
28908	SUPPL	2013-11-12
16625	SUPPL	2013-02-26
28905	SUPPL	2013-02-25
16628	SUPPL	2012-06-11
28907	SUPPL	2012-06-07
6522	SUPPL	2012-01-03
44487	ORIG	2011-12-30
37938	SUPPL	2011-12-28
37937	SUPPL	2011-07-21
28906	SUPPL	2011-07-21
6521	SUPPL	2011-01-25
16627	SUPPL	2011-01-24
6520	SUPPL	2010-01-25
16626	SUPPL	2009-12-11
16624	SUPPL	2008-02-14
6519	SUPPL	2008-02-14
42355	ORIG	2007-12-06
23687	ORIG	2007-09-26
37936	SUPPL	2007-05-01
6518	SUPPL	2007-05-01
28904	SUPPL	2007-03-07
16623	SUPPL	2007-03-07
6517	ORIG	2006-10-02
37935	ORIG	2006-09-26