FDA.reportPublic FDA data

Application 218654

Type
ANDA
Sponsor
HETERO LABS LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLRIAMFETOLSOLRIAMFETOLTABLET300MGNoNo
002SOLRIAMFETOLSOLRIAMFETOLTABLET75MGNoNo
003SOLRIAMFETOLSOLRIAMFETOLTABLET150MGNoNo

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
SUNOSISOLRIAMFETOLAxsome Therapeutics, Inc.362f206b-73e7-4009-8c34-5a9df55679ab2026-05-05Warnings, Adverse reactionsName fallback
generic name: SOLRIAMFETOL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81201ORIG 2025-02-10