Application 210388

Type: ANDA
Sponsor: JUBILANT GENERICS

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 43.

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
A210388-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06
A210388-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06
A210388-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06
A210388-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06
A210388-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210388-001	AB
A210388-002	AB
A210388-003	AB
A210388-004	AB
A210388-005	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 2 · 50 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
2026-09-14 22:38:34	2026-08	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2024-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2024-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2024-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2024-12-06	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	A210388-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210388-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210388-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210388-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210388-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210388-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210388-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210388-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210388-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210388-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210388-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210388-005	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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	Proficient Rx LP	fa9f0d28-c525-4a1e-acec-84c82e10b9a2	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LURASIDONE HYDROCHLORIDE generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Cipla USA, Inc.	76c055aa-d96a-42e5-a670-1db63b9c1dd6	2025-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	4223e7f8-acbb-4738-9b77-ddc3405afb25	2025-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	1cc441b3-0a23-4c68-a90e-436030b7daf2	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Dr. Reddys Laboratories Inc	9b512af1-98ab-1242-10e8-9534a002306e	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Latuda	LURASIDONE HYDROCHLORIDE	Sumitomo Pharma America, Inc.	afad3051-9df2-4c54-9684-e8262a133af8	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	NorthStar RxLLC	10a88607-0b5e-4707-b0cb-40c58a5c6774	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	American Health Packaging	b83e1015-8016-4c7c-8239-8dba3a882e46	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Zydus Lifesciences Limited	0f5f8228-1304-4981-8577-029136627260	2024-11-30		Name fallback brand name: Lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	84648adf-b3c6-476e-8d11-2a9d7c5eb550	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	A-S Medication Solutions	c96cbfc9-773b-410a-ada3-2822cbd58f8f	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	A-S Medication Solutions	b848e6f3-63c0-4d2e-bda5-c9e961472092	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	cecfd4c8-bff3-44fa-b360-b3e8a8e955f5	2023-12-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	A-S Medication Solutions	3cd2da15-4d51-4e5c-b683-1936dc19e234	2023-04-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lurasidone hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	2023-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Dr. Reddys Laboratories Inc	2f22a0bd-94f3-53d7-717c-03da8e1a7e97	2023-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lurasidone Hydrochloride generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Ascend Laboratories, LLC	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	2023-01-06	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.