FDA.reportPublic FDA data

Application 218393

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIPONIMODSIPONIMODTABLET0.25MGNoNo
002SIPONIMODSIPONIMODTABLET2MGNoNo
003SIPONIMODSIPONIMODTABLET1MGNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAYZENTSIPONIMODNovartis Pharmaceuticals Corporation44492772-5aed-4627-bd85-e8e89f308bb32026-06-30Warnings, Adverse reactionsName fallback
generic name: SIPONIMOD