FDA.reportPublic FDA data

Application 215126

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIFITEGRASTLIFITEGRASTSOLUTION/DROPS;OPHTHALMIC5%NoNo

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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XiidraLIFITEGRASTNovartis Pharmaceuticals Corporation8589d376-ac10-4ddb-9c53-2e0c8d5675c42025-08-18Adverse reactionsName fallback
generic name: LIFITEGRAST
XiidraLIFITEGRASTBausch & Lomb Incorporated1a914080-a3c0-44be-b601-0ae3160e77eb2024-11-21Adverse reactionsName fallback
generic name: LIFITEGRAST
LifitegrastLIFITEGRASTAurobindo Pharma Limited1d4b4b61-79da-4b6f-bb19-056d111bf4002023-11-13Adverse reactionsName fallback
brand name: Lifitegrast
generic name: LIFITEGRAST

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73411ORIG 2023-02-08