FDA.reportPublic FDA data

Application 215139

Type
ANDA
Sponsor
ANNORA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID;ORAL1.1G/MLNoNo

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 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATE ORALCamber Pharmaceuticals, Inc.d3b52ded-b305-445c-b943-ef0fb2dedd2b2026-08-24Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATENavinta LLC15c4da9f-f5e0-4628-b55f-3730be3e1c392026-06-23Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATENovadoz Pharmaceuticals LLCb4dc2c81-3b30-4bb8-af7d-4d093981c3862026-04-16Warnings, Adverse reactionsName fallback
brand name: Glycerol phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEAurobindo Pharma Limited11981aec-dbf1-4906-acfd-3c10708fe0a62026-04-09Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEZydus Pharmaceuticals USA Inc.c094cb63-3aa0-4564-9c53-7e78f2a563672026-04-01Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
RavictiGLYCEROL PHENYLBUTYRATEHorizon Therapeutics USA, Inc.900e7dc0-9afe-4f50-80de-90567bb785192025-10-29Warnings, Adverse reactionsName fallback
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATE ORALPar Health USA, LLCe78f2dfd-fb39-4e4b-a639-64591d282ca62025-10-09Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATELupin Pharmaceuticals, Inc.9bfa912f-c86c-4702-ac99-464c4356d80c2025-06-30Warnings, Adverse reactionsName fallback
brand name: glycerol phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATETeva Pharmaceuticals, Inc.28bb5ec0-a99f-4774-b8a8-b6c229b89ba52025-03-01Warnings, Adverse reactionsName fallback
brand name: Glycerol phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE

Reported adverse events (FAERS/openFDA)#

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