Application 022008

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REQUIP XL	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	Yes	Yes
002	REQUIP XL	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	REQUIP XL	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	Yes	No
004	REQUIP XL	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE	Yes	No
005	REQUIP XL	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 12MG BASE	Yes	No
006	REQUIP XL	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 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
N022008-001	REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13
N022008-002	REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13
N022008-003	REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13
N022008-004	REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13
N022008-005	REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31
N022008-006	REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10

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	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022008-005	REQUIP XL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022008-006	REQUIP XL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022008-005	REQUIP XL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022008-006	REQUIP XL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022008-005	REQUIP XL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022008-006	REQUIP XL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022008-005	REQUIP XL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022008-006	REQUIP XL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022008-005	REQUIP XL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022008-006	REQUIP XL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022008-005	REQUIP XL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022008-006	REQUIP XL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022008-001	REQUIP XL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022008-002	REQUIP XL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022008-003	REQUIP XL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022008-004	REQUIP XL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-06-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022008-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-006	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022008-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022008-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022008-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022008-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022008-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022008-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022008-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022008-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-006	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 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	N022008-001	8303986	2021-04-12		Drug product	2012-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-001	7927624	2021-12-02	U-20	Drug product	2011-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-002	8303986	2021-04-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-002	7927624	2021-12-02	U-20	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-003	8303986	2021-04-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-003	7927624	2021-12-02	U-20	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-004	8303986	2021-04-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-004	7927624	2021-12-02	U-20	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-005	8303986	2021-04-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-005	7927624	2021-12-02	U-20	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-006	8303986	2021-04-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-006	7927624	2021-12-02	U-20	Drug product		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022008-001	8303986	2021-04-12		Drug product	2012-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-001	7927624	2021-12-02	U-20	Drug product	2011-05-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-002	8303986	2021-04-12		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-002	7927624	2021-12-02	U-20	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-003	8303986	2021-04-12		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-003	7927624	2021-12-02	U-20	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-004	8303986	2021-04-12		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-004	7927624	2021-12-02	U-20	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-005	8303986	2021-04-12		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-005	7927624	2021-12-02	U-20	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-006	8303986	2021-04-12		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022008-006	7927624	2021-12-02	U-20	Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-001	8303986	2021-04-12		Drug product	2012-11-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-001	7927624	2021-12-02	U-20	Drug product	2011-05-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-002	8303986	2021-04-12		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-002	7927624	2021-12-02	U-20	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-003	8303986	2021-04-12		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-003	7927624	2021-12-02	U-20	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-004	8303986	2021-04-12		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-004	7927624	2021-12-02	U-20	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-005	8303986	2021-04-12		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-005	7927624	2021-12-02	U-20	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-006	8303986	2021-04-12		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022008-006	7927624	2021-12-02	U-20	Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022008-001	8303986	2021-04-12		Drug product	2012-11-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022008-001	7927624	2021-12-02	U-20	Drug product	2011-05-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022008-002	8303986	2021-04-12		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022008-002	7927624	2021-12-02	U-20	Drug product		`5aa47cf7b7d7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022008-001	M-203	2020-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-002	M-203	2020-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-003	M-203	2020-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-004	M-203	2020-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-005	M-203	2020-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022008-006	M-203	2020-03-23	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022008-001	M-203	2020-03-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-002	M-203	2020-03-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-003	M-203	2020-03-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-004	M-203	2020-03-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-005	M-203	2020-03-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022008-006	M-203	2020-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022008-001	M-203	2020-03-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-002	M-203	2020-03-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-003	M-203	2020-03-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-004	M-203	2020-03-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-005	M-203	2020-03-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022008-006	M-203	2020-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022008-001	M-203	2020-03-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-002	M-203	2020-03-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-003	M-203	2020-03-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-004	M-203	2020-03-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-005	M-203	2020-03-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022008-006	M-203	2020-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022008-001	M-203	2020-03-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-002	M-203	2020-03-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-003	M-203	2020-03-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-004	M-203	2020-03-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-005	M-203	2020-03-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022008-006	M-203	2020-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022008-001	M-203	2020-03-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-002	M-203	2020-03-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-003	M-203	2020-03-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-004	M-203	2020-03-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-005	M-203	2020-03-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022008-006	M-203	2020-03-23	`ea99ee380514…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	a97d5e2d-4a17-4d80-9216-1b0780199502	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Northwind Health Company, LLC	ab6d21b6-2584-4b97-e053-2a95a90adc50	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	5823b3a2-3256-4d94-97b4-ec6b940312f4	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	3b8bb729-e084-4d45-9774-63cae192be32	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	AvKARE	abd344d9-7635-62a2-d4e1-38fc46937397	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	AvPAK	e699a31a-25fc-554b-e053-2a95a90a843a	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	American Health Packaging	6849b3c0-e36b-4bea-82f2-b33ae3d44c95	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	48a63d7e-c0af-4b09-863c-2af7beb2e80f	2024-10-24	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	00c0ab77-914a-4e8a-bcb7-24cecacfebb1	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	6c10444a-48da-469d-bf8f-1e6e0b7e15f8	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Proficient Rx LP	89e3865c-1fe1-4f29-9606-8830df4bbe53	2023-08-01	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	9c4dacc6-cebc-4f42-85fc-41083512b290	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: ROPINIROLE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0007-4882	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4882	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4883	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4883	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4885	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4887	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4887	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4888	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current
0007-4888	REQUIP	ropinirole hydrochloride	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68104	SUPPL	2021-07-16
68103	SUPPL	2021-07-16
68077	SUPPL	2021-07-14
68076	SUPPL	2021-07-14
47699	SUPPL	2017-03-24
47663	SUPPL	2017-03-24
38074	SUPPL	2014-09-03
38073	SUPPL	2014-09-03
16757	SUPPL	2014-09-03
16756	SUPPL	2014-09-03
29063	SUPPL	2014-09-02
29062	SUPPL	2014-09-02
6673	SUPPL	2014-09-02
6672	SUPPL	2014-09-02
29061	SUPPL	2009-04-16
16755	SUPPL	2009-04-16
21903	ORIG	2008-12-29
16754	SUPPL	2008-11-07
6671	SUPPL	2008-11-03
16753	ORIG	2008-07-09
29060	ORIG	2008-07-08
29059	ORIG	2008-06-20