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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEExelan Pharmaceuticals Inc.4223e7f8-acbb-4738-9b77-ddc3405afb252025-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAlembic Pharmaceuticals Inc.1cc441b3-0a23-4c68-a90e-436030b7daf22025-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEDr. Reddys Laboratories Inc9b512af1-98ab-1242-10e8-9534a002306e2025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmneal Pharmaceuticals LLC6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
LatudaLURASIDONE HYDROCHLORIDESumitomo Pharma America, Inc.afad3051-9df2-4c54-9684-e8262a133af82025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDENorthStar RxLLC10a88607-0b5e-4707-b0cb-40c58a5c67742025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmerican Health Packagingb83e1015-8016-4c7c-8239-8dba3a882e462025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEZydus Lifesciences Limited0f5f8228-1304-4981-8577-0291366272602024-11-30Name fallback
brand name: Lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC84648adf-b3c6-476e-8d11-2a9d7c5eb5502024-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutionsc96cbfc9-773b-410a-ada3-2822cbd58f8f2024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutionsb848e6f3-63c0-4d2e-bda5-c9e9614720922024-02-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEMAJOR PHARMACEUTICALScecfd4c8-bff3-44fa-b360-b3e8a8e955f52023-12-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutions3cd2da15-4d51-4e5c-b683-1936dc19e2342023-04-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lurasidone hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAlembic Pharmaceuticals Limited27f70e15-ee22-47ae-ba87-20e2b4a1a4d62023-01-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEDr. Reddys Laboratories Inc2f22a0bd-94f3-53d7-717c-03da8e1a7e972023-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lurasidone Hydrochloride
generic name: LURASIDONE HYDROCHLORIDE
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEAscend Laboratories, LLC36b6bacd-ac11-493b-a8a4-8dad448ed9d52023-01-06Boxed 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