Application 021829

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEUPRO	ROTIGOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	2MG/24HR	Yes	Yes
002	NEUPRO	ROTIGOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	4MG/24HR	Yes	No
003	NEUPRO	ROTIGOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	6MG/24HR	Yes	No
004	NEUPRO	ROTIGOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	1MG/24HR	Yes	No
005	NEUPRO	ROTIGOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	3MG/24HR	Yes	No
006	NEUPRO	ROTIGOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	8MG/24HR	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
N021829-001	NEUPRO	ROTIGOTINE	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09
N021829-002	NEUPRO	ROTIGOTINE	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09
N021829-003	NEUPRO	ROTIGOTINE	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09
N021829-004	NEUPRO	ROTIGOTINE	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02
N021829-005	NEUPRO	ROTIGOTINE	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02
N021829-006	NEUPRO	ROTIGOTINE	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021829-001	8246979	2027-09-01	U-1272	Drug product	2012-09-11
N021829-001	8246979	2027-09-01	U-1273	Drug product	2012-09-11
N021829-001	10130589	2030-12-22		Drug product	2018-11-30
N021829-001	10350174	2030-12-22		Drug product	2019-07-18
N021829-001	9925150	2032-03-01		Drug product	2018-04-02
N021829-002	8246979	2027-09-01	U-1272	Drug product
N021829-002	8246979	2027-09-01	U-1273	Drug product
N021829-002	10130589	2030-12-22		Drug product	2018-11-30
N021829-002	10350174	2030-12-22		Drug product	2019-07-18
N021829-002	9925150	2032-03-01		Drug product	2018-04-02
N021829-003	8246979	2027-09-01	U-1272	Drug product
N021829-003	8246979	2027-09-01	U-1273	Drug product
N021829-003	10130589	2030-12-22		Drug product	2018-11-30
N021829-003	10350174	2030-12-22		Drug product	2019-07-18
N021829-003	9925150	2032-03-01		Drug product	2018-04-02
N021829-004	8246979	2027-09-01	U-1272	Drug product
N021829-004	8246979	2027-09-01	U-1273	Drug product
N021829-004	10130589	2030-12-22		Drug product	2018-11-30
N021829-004	10350174	2030-12-22		Drug product	2019-07-18
N021829-004	9925150	2032-03-01		Drug product	2018-04-02
N021829-005	8246979	2027-09-01	U-1272	Drug product
N021829-005	8246979	2027-09-01	U-1273	Drug product
N021829-005	10130589	2030-12-22		Drug product	2018-11-30
N021829-005	10350174	2030-12-22		Drug product	2019-07-18
N021829-005	9925150	2032-03-01		Drug product	2018-04-02
N021829-006	8246979	2027-09-01	U-1272	Drug product
N021829-006	8246979	2027-09-01	U-1273	Drug product
N021829-006	10130589	2030-12-22		Drug product	2018-11-30
N021829-006	10350174	2030-12-22		Drug product	2019-07-18
N021829-006	9925150	2032-03-01		Drug product	2018-04-02

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	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-005	NEUPRO	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-006	NEUPRO	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-005	NEUPRO	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-006	NEUPRO	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021829-005	NEUPRO	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021829-006	NEUPRO	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021829-005	NEUPRO	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021829-006	NEUPRO	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021829-005	NEUPRO	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021829-006	NEUPRO	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021829-005	NEUPRO	3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021829-006	NEUPRO	8MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021829-001	NEUPRO	2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2007-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021829-002	NEUPRO	4MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021829-003	NEUPRO	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2007-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021829-004	NEUPRO	1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2012-04-02	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,776 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021829-001	8246979	2027-09-01	U-1272	Drug product	2012-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-001	8246979	2027-09-01	U-1273	Drug product	2012-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-001	10130589	2030-12-22		Drug product	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-001	10350174	2030-12-22		Drug product	2019-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-001	9925150	2032-03-01		Drug product	2018-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-002	8246979	2027-09-01	U-1272	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-002	8246979	2027-09-01	U-1273	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-002	10130589	2030-12-22		Drug product	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-002	10350174	2030-12-22		Drug product	2019-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-002	9925150	2032-03-01		Drug product	2018-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-003	8246979	2027-09-01	U-1272	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-003	8246979	2027-09-01	U-1273	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-003	10130589	2030-12-22		Drug product	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-003	10350174	2030-12-22		Drug product	2019-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-003	9925150	2032-03-01		Drug product	2018-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-004	8246979	2027-09-01	U-1272	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-004	8246979	2027-09-01	U-1273	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-004	10130589	2030-12-22		Drug product	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-004	10350174	2030-12-22		Drug product	2019-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-004	9925150	2032-03-01		Drug product	2018-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-005	8246979	2027-09-01	U-1273	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-005	8246979	2027-09-01	U-1272	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-005	10130589	2030-12-22		Drug product	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-005	10350174	2030-12-22		Drug product	2019-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-005	9925150	2032-03-01		Drug product	2018-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-006	8246979	2027-09-01	U-1273	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-006	8246979	2027-09-01	U-1272	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-006	10130589	2030-12-22		Drug product	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-006	10350174	2030-12-22		Drug product	2019-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021829-006	9925150	2032-03-01		Drug product	2018-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021829-001	8246979	2027-09-01	U-1272	Drug product	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-001	8246979	2027-09-01	U-1273	Drug product	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-001	10130589	2030-12-22		Drug product	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-001	10350174	2030-12-22		Drug product	2019-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-001	9925150	2032-03-01		Drug product	2018-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-002	8246979	2027-09-01	U-1272	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-002	8246979	2027-09-01	U-1273	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-002	10130589	2030-12-22		Drug product	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-002	10350174	2030-12-22		Drug product	2019-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021829-002	9925150	2032-03-01		Drug product	2018-04-02	`caaa826d4ba7…`

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 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-801	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-801	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-801	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-801	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-801	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-802	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-802	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-802	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-802	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-802	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-803	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-803	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-803	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-803	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-803	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-804	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-804	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-804	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-804	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-804	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-805	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-805	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-805	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-805	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-805	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-806	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-806	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-806	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-806	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-806	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-808	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-808	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-808	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-808	Neupro	rotigotine	UCB, Inc.	NDA	Current
50474-808	Neupro	rotigotine	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68089	SUPPL	2021-07-14
68088	SUPPL	2021-07-14
68075	SUPPL	2021-07-14
68074	SUPPL	2021-07-14
62825	SUPPL	2020-05-05
62694	SUPPL	2020-04-28
62688	SUPPL	2020-04-27
62447	SUPPL	2020-04-06
57300	SUPPL	2019-01-22
57289	SUPPL	2019-01-22
56818	SUPPL	2018-12-20
56601	SUPPL	2018-11-30
16430	SUPPL	2015-03-02
28670	SUPPL	2015-02-27
28669	SUPPL	2012-04-04
6274	SUPPL	2012-04-04
44992	SUPPL	2012-04-02
44991	SUPPL	2012-04-02
37730	SUPPL	2012-04-02
37729	SUPPL	2012-04-02
21836	ORIG	2007-07-02
28668	ORIG	2007-05-16
23076	ORIG	2007-05-10
16429	ORIG	2007-05-10