Application 090429

Type: ANDA
Sponsor: ALEMBIC LTD

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 1.

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	Approval date
A090429-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090429-001	AB
A090429-002	AB
A090429-003	AB
A090429-004	AB
A090429-005	AB
A090429-006	AB
A090429-007	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 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090429-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090429-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-005	AB	1	`03ed91905a0d…`

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	ROPINIROLE	Cardinal Health 107, LLC	7bf874a3-4d45-41ab-9796-6729f409031c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 55154-7888 ndc (product): 55154-7633
ROPINIROLE	ROPINIROLE	Major Pharmaceuticals	e7ef58c0-73ba-4af2-b82b-a33954ec44df	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 0904-6373 ndc (product): 0904-6374
ROPINIROLE	ROPINIROLE	Alembic Pharmaceuticals Limited	9a25f575-09ab-4d32-b73e-5426f08c00c4	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 46708-034 ndc (product): 46708-036 ndc (product): 46708-032 ndc (product): 46708-033 ndc (product): 46708-030 ndc (product): 46708-031 ndc (product): 46708-035
ROPINIROLE	ROPINIROLE	Alembic Pharmaceuticals Inc.	6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 62332-031 ndc (product): 62332-030 ndc (product): 62332-035 ndc (product): 62332-036 ndc (product): 62332-033 ndc (product): 62332-032 ndc (product): 62332-034
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	3b8bb729-e084-4d45-9774-63cae192be32	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE	ROPINIROLE	Coupler LLC	2cd9b1e8-5856-4b79-e063-6394a90ab260	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE	ROPINIROLE	Coupler LLC	2cdae415-479b-c14c-e063-6394a90adb6c	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	48a63d7e-c0af-4b09-863c-2af7beb2e80f	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 0615-8189 ndc (product): 0615-8191 ndc (product): 0615-8188 ndc (product): 0615-8190
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	00c0ab77-914a-4e8a-bcb7-24cecacfebb1	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 71335-0727

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8188	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8188	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8189	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8189	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8190	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8190	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8191	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8191	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
21695-793	ropinirole hydrochloride	ropinirole hydrochloride	Rebel Distributors Corp	ANDA	Current
46708-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
50090-3304	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-3304	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-3304	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
53217-166	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-7633	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-7633	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health 107, LLC	ANDA	Current
55154-7888	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-7888	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-7888	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health 107, LLC	ANDA	Current
61919-564	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-780	ROPINIROLE	ROPINIROLE	Direct_Rx	ANDA	Current
61919-780	ROPINIROLE	ROPINIROLE	Direct_Rx	ANDA	Current
61919-780	ROPINIROLE	ROPINIROLE	Direct_Rx	ANDA	Current
62332-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
63629-4971	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4977	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68258-7162	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
71335-0727	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0727	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0727	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0728	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0728	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current