FDA.reportPublic FDA data

Application 208038

Type
ANDA
Sponsor
US GENERICS, STERILES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLNALTREXONE BROMIDEMETHYLNALTREXONE BROMIDESOLUTION;SUBCUTANEOUS12MG/0.6MLNoNo

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
RelistorMETHYLNALTREXONE BROMIDESalix Pharmaceuticals, Inc.c488fb7c-0a5b-487c-b452-996809d1cb992024-05-01Warnings, Adverse reactionsName fallback
generic name: METHYLNALTREXONE BROMIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68529ORIG2021-09-02