FDA.reportPublic FDA data

Application 022072

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPRYCELDASATINIBTABLET; ORAL70MGNoNo

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 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DASATINIBDASATINIBAurobindo Pharma Limited58ce42c6-10bd-4bb4-bf89-eae8ed82c3392026-07-27Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DASATINIBDASATINIBNorthStar RxLLCf9b79d54-9bee-4c93-9c87-f3e65d91f1462026-05-28Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBBluePoint Laboratories02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42026-03-05Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBLupin Pharmaceuticals, Inc.f60261dd-b8ea-4511-bed6-ad6d7f4dd8282026-02-27Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBAvKARE43e078b9-4e0b-edeb-e063-6294a90a75862025-11-18Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DASATINIBDASATINIBAlembic Pharmaceuticals Limited645fcf26-1b2f-40c5-881b-8effe02defbd2025-11-12Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DASATINIBDASATINIBAlembic Pharmaceuticals Inc.de3215a4-d098-4bc3-ad81-c7c9e34938722025-11-11Warnings, Adverse reactionsName fallback
generic name: DASATINIB
PHYRAGODASATINIBCycle Pharmaceuticals Ltd60976d1e-c415-417f-8168-4e07999a72812025-08-23Warnings, Adverse reactionsName fallback
generic name: DASATINIB
dasatinibDASATINIBZydus Lifesciences Limited4eed6b7b-a09d-4d2e-a345-968dd68323bc2025-03-04Name fallback
generic name: DASATINIB
DasatinibDASATINIBDr.Reddys Laboratories Inceb5ddff2-6521-b461-43ac-80ff8660b20b2025-03-03Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBBiocon Pharma Inc.76e1833c-e105-5a3d-0f01-1330d8cc7ae12025-02-25Warnings, Adverse reactionsName fallback
generic name: DASATINIB
dasatinibDASATINIBZydus Pharmaceuticals USA Inc.11703145-29ea-480a-9810-bc70663b783f2024-09-10Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBApotex Corp.2ed87763-f018-abdb-c0ab-daa5e441b3972024-09-04Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBTeva Pharmaceuticals, Inc.3000fd91-1b09-4d72-8522-1ca5e35ed9562024-08-01Warnings, Adverse reactionsName fallback
generic name: DASATINIB
DasatinibDASATINIBPrasco Laboratories1931e73f-918c-4d69-9543-de9643513d052024-07-09Warnings, Adverse reactionsName fallback
generic name: DASATINIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29204SUPPL2010-08-09
29203SUPPL2008-06-03
42408ORIG2006-09-06
16895ORIG2006-07-03
6828ORIG2006-07-03