FDA.reportPublic FDA data

Application 213713

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFAXIMINRIFAXIMINTABLET;ORAL550MGNoNo

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
XIFAXANRIFAXIMINCardinal Health 107, LLC7afafa63-3236-4212-9589-045db6b01c0b2025-08-27Warnings, Adverse reactionsName fallback
generic name: RIFAXIMIN
XIFAXANRIFAXIMINSalix Pharmaceuticals, Inc.c5e8e2fd-7087-4b78-9181-cc259c0be2f12025-06-25Warnings, Adverse reactionsName fallback
generic name: RIFAXIMIN
XIFAXANRIFAXIMINA-S Medication Solutionsf73acb74-e930-4414-81e9-d2a01db36e302023-02-04Warnings, Adverse reactionsName fallback
generic name: RIFAXIMIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74528ORIG 2023-06-16