FDA.reportPublic FDA data

Application 208016

Type
ANDA
Sponsor
WATSON LABS INC

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
A208016-001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE20MGTABLET / ORAL2021-02-02
A208016-002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE40MGTABLET / ORAL2021-02-02
A208016-003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE60MGTABLET / ORAL2021-02-02
A208016-004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE80MGTABLET / ORAL2021-02-02
A208016-005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE120MGTABLET / ORAL2021-02-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208016-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORAL2021-02-02a50c72e98297…
2026-08-01 22:54:322026-06A208016-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORAL2021-02-02a50c72e98297…
2026-08-01 22:54:322026-06A208016-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORAL2021-02-02a50c72e98297…
2026-08-01 22:54:322026-06A208016-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORAL2021-02-02a50c72e98297…
2026-08-01 22:54:322026-06A208016-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORAL2021-02-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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