Application 079165

Type: ANDA
Sponsor: MLV

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
A079165-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07
A079165-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07
A079165-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07
A079165-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07
A079165-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07
A079165-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-02-07
A079165-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079165-001	AB
A079165-002	AB
A079165-003	AB
A079165-004	AB
A079165-005	AB
A079165-006	AB
A079165-007	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	A079165-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079165-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-02-07	`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	A079165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079165-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079165-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079165-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079165-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079165-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079165-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ropinirole	ROPINIROLE	Marlex Pharmaceuticals Inc	35d90f6f-3116-4afa-be2d-b65c160e8ab3	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079165 application number: ANDA079165 ndc (product): 10135-679 ndc (product): 10135-673 ndc (product): 10135-677 ndc (product): 10135-675 ndc (product): 10135-676 ndc (product): 10135-674 ndc (product): 10135-678

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-673	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-673	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-673	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-673	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-673	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-674	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-674	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-674	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-674	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-674	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-675	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-675	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-675	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-675	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-675	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-676	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-676	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-676	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-676	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-676	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-677	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-677	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-677	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-677	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-677	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-678	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-678	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-678	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-678	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-678	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-679	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-679	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-679	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-679	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
10135-679	Ropinirole	ropinirole	Marlex Pharmaceuticals Inc	ANDA	Current
60505-2865	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current
60505-2866	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current
60505-2867	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current
60505-2868	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current
60505-2869	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current
60505-2870	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current
60505-2871	Ropinirole	Ropinirole	Apotex Corp.	ANDA	Current