Application 077460

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 0.25MG BASE	No	No
002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 0.5MG BASE	No	No
003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	No	No
004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE	No	No
005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 3MG BASE	No	No
006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	No	No
007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077460-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05
A077460-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05
A077460-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05
A077460-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05
A077460-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05
A077460-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05
A077460-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19

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 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077460-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077460-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077460-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077460-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077460-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077460-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077460-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077460-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077460-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077460-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077460-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077460-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077460-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077460-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077460-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077460-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077460-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077460-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077460-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077460-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077460-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077460-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077460-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077460-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077460-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077460-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077460-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077460-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077460-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077460-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077460-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077460-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077460-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077460-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`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 · 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 brand name: ropinirole hydrochloride 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 brand name: ropinirole hydrochloride 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 brand name: ropinirole hydrochloride 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 brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	3b8bb729-e084-4d45-9774-63cae192be32	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	AvKARE	abd344d9-7635-62a2-d4e1-38fc46937397	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	AvPAK	e699a31a-25fc-554b-e053-2a95a90a843a	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	American Health Packaging	6849b3c0-e36b-4bea-82f2-b33ae3d44c95	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: ropinirole hydrochloride 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 brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	00c0ab77-914a-4e8a-bcb7-24cecacfebb1	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	6c10444a-48da-469d-bf8f-1e6e0b7e15f8	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Proficient Rx LP	89e3865c-1fe1-4f29-9606-8830df4bbe53	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: ropinirole hydrochloride 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 brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18463	ORIG	2008-07-14
31241	ORIG	2008-05-07