Application 020747

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.2MG BASE	Yes	No
002	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.4MG BASE	Yes	Yes
003	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.6MG BASE	Yes	No
004	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.8MG BASE	Yes	No
005	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.2MG BASE	Yes	No
006	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.6MG BASE	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
N020747-001	ACTIQ	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-002	ACTIQ	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-003	ACTIQ	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-004	ACTIQ	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-005	ACTIQ	FENTANYL CITRATE	EQ 1.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-006	ACTIQ	FENTANYL CITRATE	EQ 1.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04

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	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020747-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020747-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020747-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020747-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020747-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-004	AB	1	`87673890dc5c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fentanyl Citrate	FENTANYL CITRATE	Teva Pharmaceuticals USA, Inc.	78221eab-66fd-4cd8-9c81-af52eb83671c	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020747 application number: NDA020747 ndc (product): 0093-7868 ndc (product): 0093-7867 ndc (product): 0093-7870 ndc (product): 0093-7866 ndc (product): 0093-7869 ndc (product): 0093-7865

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 99 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
52959-548	Transmucosal Fentanyl Citrate	fentanyl citrate	H.J. Harkins Company, Inc.	NDA	Current
52959-549	Transmucosal Fentanyl Citrate	fentanyl citrate	H.J. Harkins Company, Inc.	NDA	Current
52959-566	Transmucosal Fentanyl Citrate	fentanyl citrate	H.J. Harkins Company, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84672	SUPPL	2026-01-06
84565	SUPPL	2025-12-29
80159	SUPPL	2024-11-05
79500	SUPPL	2024-08-29
76997	SUPPL	2023-12-19
76900	SUPPL	2023-12-18
76899	SUPPL	2023-12-18
72853	SUPPL	2022-12-09
72707	SUPPL	2022-11-25
72682	SUPPL	2022-11-23
72681	SUPPL	2022-11-23
71844	SUPPL	2022-08-18
69493	SUPPL	2021-12-07
66589	SUPPL	2021-03-08
66588	SUPPL	2021-03-08
66564	SUPPL	2021-03-08
65765	SUPPL	2020-12-28
60488	SUPPL	2019-10-09
60487	SUPPL	2019-10-09
60426	SUPPL	2019-10-09
49710	SUPPL	2017-09-11
46365	SUPPL	2016-12-21
46364	SUPPL	2016-12-21
46268	SUPPL	2016-12-20
46267	SUPPL	2016-12-20
25696	SUPPL	2014-12-30
25695	SUPPL	2013-11-08
13340	SUPPL	2012-06-11
25694	SUPPL	2012-06-07
20895	SUPPL	2012-02-28
25693	SUPPL	2012-01-03
44460	ORIG	2011-12-30
35268	SUPPL	2011-12-28
25692	SUPPL	2011-07-21
13338	SUPPL	2011-07-21
3260	SUPPL	2010-01-20
13339	SUPPL	2009-11-13
20896	SUPPL	2008-07-30
25690	SUPPL	2007-04-11
13337	SUPPL	2007-02-21
25691	SUPPL	2007-02-12
35267	SUPPL	2006-09-12
35266	SUPPL	2005-09-15
25689	SUPPL	2005-09-15
25688	SUPPL	2005-01-26
13336	SUPPL	2004-09-29
3259	SUPPL	2004-09-29
3256	SUPPL	2003-02-19
25687	SUPPL	2003-01-29
3258	SUPPL	2002-06-10
3257	SUPPL	2002-03-07
25686	SUPPL	2001-04-11
41641	ORIG	2000-07-19
13335	ORIG	1998-11-04
3255	ORIG	1998-11-04