Application 078110

Type: ANDA
Sponsor: PRINSTON INC

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	TE codes	RLD / RS	Approval date
A078110-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05
A078110-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A078110-001	AB
A078110-002	AB
A078110-003	AB
A078110-004	AB
A078110-005	AB
A078110-006	AB
A078110-007	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078110-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078110-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078110-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078110-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078110-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-005	AB	1	`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 · 9 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	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Northwind Health Company, LLC	ab6d21b6-2584-4b97-e053-2a95a90adc50	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	5823b3a2-3256-4d94-97b4-ec6b940312f4	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	AvPAK	e699a31a-25fc-554b-e053-2a95a90a843a	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	American Health Packaging	6849b3c0-e36b-4bea-82f2-b33ae3d44c95	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	6c10444a-48da-469d-bf8f-1e6e0b7e15f8	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110 ndc (product): 71335-0587 ndc (product): 71335-1434 ndc (product): 71335-1626
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Proficient Rx LP	89e3865c-1fe1-4f29-9606-8830df4bbe53	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	9c4dacc6-cebc-4f42-85fc-41083512b290	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110

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 2 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64220-425	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Zhejiang Huahai Pharmaceutical Co., Ltd.	ANDA	Current
64220-426	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Zhejiang Huahai Pharmaceutical Co., Ltd.	ANDA	Current
70518-2476	ropinirole hydrochloride	ropinirole hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2476	ropinirole hydrochloride	ropinirole hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2476	ropinirole hydrochloride	ropinirole hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2476	ropinirole hydrochloride	ropinirole hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0587	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0587	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1434	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1434	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1434	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1626	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1626	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1626	ropinirole hydrochloride	ropinirole hydrochloride	Bryant Ranch Prepack	ANDA	Current