Application 213248

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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 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
A213248-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13
A213248-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13
A213248-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13
A213248-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13
A213248-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213248-001	AB
A213248-002	AB
A213248-003	AB
A213248-004	AB
A213248-005	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 5 · 165 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	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 165 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	A213248-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213248-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213248-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213248-005	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Coupler LLC	4aa17493-69eb-9dc7-e063-6294a90a4c0b	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Coupler LLC	4742c2fd-303b-da08-e063-6294a90a7621	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	1cc441b3-0a23-4c68-a90e-436030b7daf2	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248 ndc (product): 62332-497 ndc (product): 62332-495 ndc (product): 62332-496 ndc (product): 62332-498 ndc (product): 62332-494
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248 ndc (product): 46708-498 ndc (product): 46708-497 ndc (product): 46708-494 ndc (product): 46708-496 ndc (product): 46708-495

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-494	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-495	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-496	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-497	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-498	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
62332-494	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-495	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-496	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-497	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-498	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current