Application 090869

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	No	No
002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	No	No
003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 6MG BASE	No	No
004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE	No	No
005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 12MG 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090869-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A090869-001	AB
A090869-002	AB
A090869-003	AB
A090869-004	AB
A090869-005	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 6 · 205 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	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A090869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-005	AB	1	`5bbf6a4d5a75…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	AvKARE	abd344d9-7635-62a2-d4e1-38fc46937397	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090869 application number: ANDA090869
Ropinirole	ROPINIROLE	Actavis Pharma, Inc.	300946bf-2f83-471d-868d-9820b65c52bb	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090869 application number: ANDA090869 ndc (product): 0228-3660 ndc (product): 0228-3640 ndc (product): 0228-3661 ndc (product): 0228-3659 ndc (product): 0228-3658

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-3640	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3640	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3640	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3658	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3658	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3658	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3659	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3659	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3659	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3660	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3660	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3660	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3661	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3661	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current
0228-3661	Ropinirole	Ropinirole	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43243	ORIG	2012-06-22