FDA.reportPublic FDA data

Application 216074

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IVACAFTORIVACAFTORTABLET; ORAL150MGNoNo
002IVACAFTORIVACAFTORTABLET; ORAL150mgNoNo

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
KalydecoIVACAFTORVertex Pharmaceuticals Incorporated0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe252026-03-23Warnings, Adverse reactionsName fallback
generic name: IVACAFTOR