Application 212244

Type: ANDA
Sponsor: ALKEM LABS 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 42.

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
A212244-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13
A212244-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13
A212244-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13
A212244-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13
A212244-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212244-001	AB
A212244-002	AB
A212244-003	AB
A212244-004	AB
A212244-005	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 4 · 125 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
2026-08-18 06:07:40	2026-07	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212244-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212244-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212244-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-005	AB	1	`2680178bc6a6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	6008ccac-948e-4b6a-a288-7dd245c2bac4	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Major Pharmaceuticals	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	American Health Packaging	b83e1015-8016-4c7c-8239-8dba3a882e46	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	A-S Medication Solutions	c96cbfc9-773b-410a-ada3-2822cbd58f8f	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Ascend Laboratories, LLC	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	2023-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244 ndc (product): 67877-639 ndc (product): 67877-641 ndc (product): 67877-642 ndc (product): 67877-638 ndc (product): 67877-640

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-638	lurasidone hydrochloride	lurasidone hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-639	lurasidone hydrochloride	lurasidone hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-640	lurasidone hydrochloride	lurasidone hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-641	lurasidone hydrochloride	lurasidone hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-642	lurasidone hydrochloride	lurasidone hydrochloride	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63034	ORIG	2020-05-15