FDA.reportPublic FDA data

Application 218228

Type
ANDA
Sponsor
CIPLA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIPONIMODSIPONIMODTABLET;ORAL0.25MGNoNo
002SIPONIMODSIPONIMODTABLET;ORAL1MGNoNo
003SIPONIMODSIPONIMODTABLET;ORAL2MGNoNo

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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81322ORIG 2025-02-24