FDA.reportPublic FDA data

Application 204130

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSAMPRENAVIR CALCIUMFOSAMPRENAVIR CALCIUMTABLET;ORAL700MGNoNo

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
Fosamprenavir CalciumFOSAMPRENAVIR CALCIUMSun Pharmaceutical Industries, Inc.5cd1eead-9fc1-426c-bee8-214ffa7d9dc12026-06-30Warnings, Adverse reactionsName fallback
brand name: Fosamprenavir Calcium
generic name: FOSAMPRENAVIR CALCIUM
Fosamprenavir CalciumFOSAMPRENAVIR CALCIUMMylan Pharmaceuticals Inc.3a1424d8-844c-4e24-9ebd-b2c2b61b61a32023-09-15Warnings, Adverse reactionsName fallback
brand name: Fosamprenavir Calcium
generic name: FOSAMPRENAVIR CALCIUM

Reported adverse events (FAERS/openFDA)#

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