FDA.reportPublic FDA data

Application 213845

Type
ANDA
Sponsor
SUNSHINE LAKE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENOFOVIR ALAFENAMIDETENOFOVIR ALAFENAMIDETABLET;ORAL25MGNoNo

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
VEMLIDYTENOFOVIR ALAFENAMIDEGilead Sciences, Inc.72e6b33c-0351-4070-9172-eeaa186c01d22025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TENOFOVIR ALAFENAMIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68381ORIG2021-08-16