FDA.reportPublic FDA data

Application 207694

Type
ANDA
Sponsor
LUPIN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207694-001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207694-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207694-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A207694-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-30caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207694-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207694-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A207694-001AA1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207694-001AA1a50c72e98297…

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 · 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.