FDA.reportPublic FDA data

Application 077611

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIBAVIRINRIBAVIRINSOLUTION; ORAL40MG/MLYesNo

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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RibavirinRIBAVIRINAurobindo Pharma Limited35f99f76-f2ef-4a81-91ff-285419664be32024-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ribavirin
generic name: RIBAVIRIN
RibavirinRIBAVIRINAurobindo Pharma Limitedeee304d0-c2ea-44f4-97d9-92a414d31b6c2024-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ribavirin
generic name: RIBAVIRIN
RibavirinRIBAVIRINOceanside Pharmaceuticalsd74aa4f3-0b7d-480d-b5bf-41ddf808b2602019-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ribavirin
generic name: RIBAVIRIN

Reported adverse events (FAERS/openFDA)#

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