Application 208016

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	40MG	No	No
003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	120MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A208016-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02
A208016-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02
A208016-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02
A208016-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02
A208016-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02

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 2 of 5 · 190 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208016-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2021-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208016-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2021-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208016-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	2021-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208016-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2021-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208016-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2021-02-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208016-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208016-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208016-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208016-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208016-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208016-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208016-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208016-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208016-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208016-005	AB	1	`5aa47cf7b7d7…`

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	a97b59db-29e8-4b00-9d35-56b47335ee25	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	6008ccac-948e-4b6a-a288-7dd245c2bac4	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	672d22f6-fad5-49db-9206-f924d02af181	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	1989d512-e568-468f-e063-6294a90a5c22	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	bceb350e-4b88-4de1-9629-9629365a27a7	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	083a1a52-5a13-4e28-8ef2-127ac4ce5b2d	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	Aurobindo Pharma Limited	b3e9cc86-0c5c-444f-ab57-f4d1a6865035	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LURASIDONE HYDROCHLORIDE generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	6d97d871-66d3-4ed8-bbc5-0620e9f69ae5	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	2b07a830-93ba-427a-95fc-5138a6309f1e	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	9cb5e275-1029-407a-8c93-ec5cde2d323b	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Coupler LLC	4aa17493-69eb-9dc7-e063-6294a90a4c0b	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	0115b2fa-4c11-4f91-abe7-8293903e066c	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	Coupler LLC	4973beed-b75b-c370-e063-6394a90a26e5	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LURASIDONE HYDROCHLORIDE generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Coupler LLC	4742c2fd-303b-da08-e063-6294a90a7621	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Accord Healthcare, Inc.	7e11ec22-63c1-41a6-899c-4fe746f76bd0	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	a101e62e-dd1f-4add-8393-ba6d54adce06	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	74f2429b-71df-47f0-9cb5-98685372a9b8	2025-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Major Pharmaceuticals	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	4f969224-a9f0-4089-84d6-a15664ea7bfe	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	c80625bb-7857-4763-81fe-542b3448d84f	2025-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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