Home Applications 217431 Application 217431
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 IVACAFTOR IVACAFTOR GRANULE;ORAL 25MG No No 003 IVACAFTOR IVACAFTOR GRANULE;ORAL 50MG No No 004 IVACAFTOR IVACAFTOR GRANULE;ORAL 75MG 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 Kalydeco IVACAFTOR Vertex Pharmaceuticals Incorporated 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25 2026-03-23 Warnings, Adverse reactions Name fallback generic name: IVACAFTOR
Documents# Document, Submission type, Date table Document Submission type Date 81314 ORIG 2025-02-24