FDA.reportPublic FDA data

Application 216799

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LETERMOVIRLETERMOVIRTABLET;ORAL240MGNoNo
002LETERMOVIRLETERMOVIRTABLET;ORAL480MGNoNo

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
PREVYMISLETERMOVIRMerck Sharp & Dohme LLC1b49df80-be4f-47e0-a0b7-123f3e69395b2026-01-14Warnings, Adverse reactionsName fallback
generic name: LETERMOVIR