FDA.reportPublic FDA data

Application 090910

Type
ANDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM PHENYLBUTYRATESODIUM PHENYLBUTYRATETABLET;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090910-001SODIUM PHENYLBUTYRATESODIUM PHENYLBUTYRATE500MGTABLET / ORAL2011-11-18

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090910-001SODIUM PHENYLBUTYRATE500MGTABLET / ORAL2011-11-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090910-001SODIUM PHENYLBUTYRATE500MGTABLET / ORAL2011-11-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090910-001SODIUM PHENYLBUTYRATE500MGTABLET / ORAL2011-11-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090910-001SODIUM PHENYLBUTYRATE500MGTABLET / ORAL2011-11-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090910-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090910-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090910-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090910-001AB1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHEBURANESODIUM PHENYLBUTYRATEMedunik USAd15f2cbf-4d22-40b5-8ef9-16b9d323a7f92026-07-17Warnings, Adverse reactionsName fallback
generic name: SODIUM PHENYLBUTYRATE
Sodium phenylbutyrateSODIUM PHENYLBUTYRATENavinta LLCc564778d-b285-4d1d-a641-9d4ee76079cf2026-07-09Warnings, Adverse reactionsName fallback
brand name: Sodium phenylbutyrate
generic name: SODIUM PHENYLBUTYRATE
Sodium phenylbutyrateSODIUM PHENYLBUTYRATEZydus Pharmaceuticals USA Inc.d08fd548-7eb8-4f6f-b664-b0fff6f300652026-04-28Warnings, Adverse reactionsName fallback
brand name: Sodium phenylbutyrate
generic name: SODIUM PHENYLBUTYRATE
Sodium PhenylbutyrateSODIUM PHENYLBUTYRATE TABLETS, 500 MGPar Health USA, LLC4020b962-eaee-4184-b04b-14ca757c51a12026-04-17Warnings, Adverse reactionsName fallback
brand name: Sodium Phenylbutyrate
Sodium PhenylbutyrateSODIUM PHENYLBUTYRATEPar Health USA, LLC639f5c7e-9f6d-47fb-a417-2be076176a782026-04-14Warnings, Adverse reactionsName fallback
brand name: Sodium Phenylbutyrate
generic name: SODIUM PHENYLBUTYRATE
sodium phenylbutyrateSODIUM PHENYLBUTYRATEGLENMARK PHARMACEUTICALS INC., USA0c76d25b-abac-41a3-a547-4fa4796bf7a42026-01-28Warnings, Adverse reactionsName fallback
brand name: sodium phenylbutyrate
generic name: SODIUM PHENYLBUTYRATE
BUPHENYLSODIUM PHENYLBUTYRATEHorizon Therapeutics USA, Inc.463a36fa-3eb2-4326-8bd0-c8c7a11bca3a2024-10-30Warnings, Adverse reactionsName fallback
generic name: SODIUM PHENYLBUTYRATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9305ORIG2011-11-28