Application 210388

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDETABLET;ORAL20MGNoNo
002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDETABLET;ORAL40MGNoNo
003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDETABLET;ORAL60MGNoNo
004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDETABLET;ORAL80MGNoNo
005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDETABLET;ORAL120MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210388-001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-06
A210388-002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-06
A210388-003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-06
A210388-004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-06
A210388-005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210388-001AB
A210388-002AB
A210388-003AB
A210388-004AB
A210388-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-062680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-12-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-12-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-12-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-12-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-12-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210388-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210388-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210388-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210388-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210388-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210388-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210388-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210388-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210388-005AB12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210388-005AB1a50c72e98297…

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.bceb350e-4b88-4de1-9629-9629365a27a72026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.083a1a52-5a13-4e28-8ef2-127ac4ce5b2d2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDEAurobindo Pharma Limitedb3e9cc86-0c5c-444f-ab57-f4d1a68650352026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LURASIDONE HYDROCHLORIDE
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.6d97d871-66d3-4ed8-bbc5-0620e9f69ae52026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEMacleods Pharmaceuticals Limited2b07a830-93ba-427a-95fc-5138a6309f1e2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDETorrent Pharmaceuticals Limited9cb5e275-1029-407a-8c93-ec5cde2d323b2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECoupler LLC4aa17493-69eb-9dc7-e063-6294a90a4c0b2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.0115b2fa-4c11-4f91-abe7-8293903e066c2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDECoupler LLC4973beed-b75b-c370-e063-6394a90a26e52026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LURASIDONE HYDROCHLORIDE
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECoupler LLC4742c2fd-303b-da08-e063-6294a90a76212025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEGolden State Medical Supply, Inc.08ba1a4c-c193-e0ea-e063-6294a90a52dc2025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEGolden State Medical Supply, Inc.1989d512-e568-468f-e063-6294a90a5c222025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEAccord Healthcare, Inc.7e11ec22-63c1-41a6-899c-4fe746f76bd02025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDETorrent Pharmaceuticals Limiteda101e62e-dd1f-4add-8393-ba6d54adce062025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.b94e9272-ed67-4af8-827a-4b8cc3b168a12025-10-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.5dc04e98-e41c-40cb-9037-d29084c9bf6d2025-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.a97b59db-29e8-4b00-9d35-56b47335ee252025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.6008ccac-948e-4b6a-a288-7dd245c2bac42025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDELupin Pharmaceuticals, Inc.74f2429b-71df-47f0-9cb5-98685372a9b82025-09-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEMajor Pharmaceuticalsd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c2025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE