Home Applications 218228 Application 218228
Type ANDA
Sponsor CIPLA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SIPONIMOD SIPONIMOD TABLET;ORAL 0.25MG No No 002 SIPONIMOD SIPONIMOD TABLET;ORAL 1MG No No 003 SIPONIMOD SIPONIMOD TABLET;ORAL 2MG No No
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MAYZENT SIPONIMOD Novartis Pharmaceuticals Corporation 44492772-5aed-4627-bd85-e8e89f308bb3 2026-06-30 Warnings, Adverse reactions Name fallback generic name: SIPONIMOD
Documents# Document, Submission type, Date table Document Submission type Date 81322 ORIG 2025-02-24