Application 019813

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DURAGESIC-100	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	Yes	No
002	DURAGESIC-75	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	Yes	No
003	DURAGESIC-50	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	Yes	No
004	DURAGESIC-25	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	Yes	Yes
005	DURAGESIC-12	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR	Yes	No
006	DURAGESIC-37	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	37.5MCG/HR	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
N019813-001	DURAGESIC-100	FENTANYL	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-002	DURAGESIC-75	FENTANYL	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-003	DURAGESIC-50	FENTANYL	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-004	DURAGESIC-25	FENTANYL	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-005	DURAGESIC-12	FENTANYL	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04
N019813-006	DURAGESIC-37	FENTANYL	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24

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	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019813-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-006	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019813-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019813-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019813-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019813-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019813-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-004	AB	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL	FENTANYL	Aveva Drug Delivery Systems Inc.	73897c38-e4ec-40bc-9f41-3359ee23a5a8	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL
FENTANYL	FENTANYL	INGENUS PHARMACEUTICALS, LLC	bf02ffd0-cc5d-446b-b648-378f6885052f	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL
Fentanyl system	FENTANYL	ALVOGEN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL
FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL

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 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7240	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7241	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7242	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7243	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7244	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
50458-090	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-090	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-090	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-091	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-091	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-092	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-092	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-092	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-093	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-093	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-093	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-094	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-094	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-094	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
63629-4765	Fentanyl	Fentanyl	Bryant Ranch Prepack	NDA	Current
68258-3040	Fentanyl	Fentanyl	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66520	SUPPL	2021-03-05
66519	SUPPL	2021-03-05
66509	SUPPL	2021-03-05
60341	SUPPL	2019-10-08
60325	SUPPL	2019-10-08
60324	SUPPL	2019-10-08
55843	SUPPL	2018-10-05
55842	SUPPL	2018-10-05
55655	SUPPL	2018-09-28
55654	SUPPL	2018-09-28
51915	SUPPL	2018-01-26
51914	SUPPL	2018-01-26
48570	SUPPL	2017-05-30
47185	SUPPL	2017-02-13
47097	SUPPL	2017-02-03
46394	SUPPL	2016-12-21
46237	SUPPL	2016-12-20
45460	SUPPL	2016-10-04
19254	SUPPL	2016-04-22
19253	SUPPL	2015-07-02
19252	SUPPL	2014-08-20
1642	SUPPL	2014-04-17
33979	SUPPL	2014-04-16
19251	SUPPL	2013-10-09
11735	SUPPL	2013-09-24
19250	SUPPL	2013-04-16
20375	SUPPL	2012-10-12
20374	SUPPL	2012-09-17
33978	SUPPL	2012-07-12
23965	ORIG	2012-07-11
19249	SUPPL	2012-07-11
19248	SUPPL	2012-07-11
33977	SUPPL	2010-04-01
41042	SUPPL	2009-01-12
41041	SUPPL	2009-01-12
41040	SUPPL	2009-01-12
20373	SUPPL	2009-01-12
20372	SUPPL	2009-01-12
20371	SUPPL	2009-01-12
20368	ORIG	2008-02-19
33974	SUPPL	2008-02-14
1639	SUPPL	2008-02-14
41039	SUPPL	2007-07-09
41038	SUPPL	2007-07-09
20370	SUPPL	2007-07-09
20369	SUPPL	2007-07-09
23557	ORIG	2005-07-29
33976	SUPPL	2005-02-08
1641	SUPPL	2005-02-08
33975	SUPPL	2003-06-08
1640	SUPPL	2003-06-08
19247	SUPPL	2001-04-11
1638	SUPPL	2001-04-11
51855	ORIG	1900-01-01
51854	ORIG	1900-01-01
51853	ORIG	1900-01-01
51852	ORIG	1900-01-01
51851	ORIG	1900-01-01