FDA.reportPublic FDA data

Application 220313

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID;ORAL1.1GM/MLNoNo
002GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID1.1G/1MLNoNo
003GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID450MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A220313-001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220313-001AA

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
2026-08-18 06:07:402026-07A220313-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220313-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220313-001AA1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220313-001AA1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEAurobindo Pharma Limited11981aec-dbf1-4906-acfd-3c10708fe0a62026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220313
application number: ANDA220313

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84995ORIG 2026-02-11