FDA.reportPublic FDA data

Application 207948

Type
ANDA
Sponsor
PAR PHARM 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.

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.a97b59db-29e8-4b00-9d35-56b47335ee252026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.6008ccac-948e-4b6a-a288-7dd245c2bac42026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.672d22f6-fad5-49db-9206-f924d02af1812026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEGolden State Medical Supply, Inc.1989d512-e568-468f-e063-6294a90a5c222026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
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 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 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 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
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDENovadoz Pharmaceuticals LLC4f969224-a9f0-4089-84d6-a15664ea7bfe2025-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECamber Pharmaceuticals, Inc.c80625bb-7857-4763-81fe-542b3448d84f2025-07-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDEProficient Rx LPfa9f0d28-c525-4a1e-acec-84c82e10b9a22025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LURASIDONE HYDROCHLORIDE
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECipla USA, Inc.76c055aa-d96a-42e5-a670-1db63b9c1dd62025-03-01Boxed warning, Warnings, Adverse reactionsName 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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48649ORIG2017-06-06