FDA.reportPublic FDA data

Application 214397

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOLUTEGRAVIR SODIUMDOLUTEGRAVIR SODIUMUNKNOWNUNKNOWNNoNo
002DOLUTEGRAVIR SODIUMDOLUTEGRAVIR SODIUMTABLET;ORALEQ 25MG BASENoNo
003DOLUTEGRAVIR SODIUMDOLUTEGRAVIR SODIUMTABLET;ORALEQ 50MG BASENoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TivicayDOLUTEGRAVIR SODIUMViiV Healthcare Company63df5af3-b8ac-4e76-9830-2dbb340af9222026-08-25Warnings, Adverse reactionsName fallback
generic name: DOLUTEGRAVIR SODIUM
TivicayDOLUTEGRAVIR SODIUMST. MARY'S MEDICAL PARK PHARMACY485bc9db-8665-9f5a-e063-6394a90a79212026-05-22Warnings, Adverse reactionsName fallback
generic name: DOLUTEGRAVIR SODIUM

Reported adverse events (FAERS/openFDA)#

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