FDA.reportPublic FDA data

Application 210297

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANAGLIFLOZINCANAGLIFLOZINTABLET; ORAL100MGNoNo

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 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INVOKANACANAGLIFLOZINJanssen Pharmaceuticals, Inc.b9057d3b-b104-4f09-8a61-c61ef9d4a3f32026-06-11Warnings, Adverse reactionsName fallback
generic name: CANAGLIFLOZIN
INVOKANACANAGLIFLOZINCardinal Health 107, LLC5f76e16f-0c24-454a-81af-4080b312c9402026-02-17Warnings, Adverse reactionsName fallback
generic name: CANAGLIFLOZIN
INVOKANACANAGLIFLOZINA-S Medication Solutions9679460c-55f7-4826-b55c-fe116f0203582023-12-15Warnings, Adverse reactionsName fallback
generic name: CANAGLIFLOZIN
INVOKANACANAGLIFLOZINA-S Medication Solutions8d5f892b-e4f3-4a9e-9a91-95e2fca341442023-12-15Warnings, Adverse reactionsName fallback
generic name: CANAGLIFLOZIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65860ORIG2021-01-07