FDA.reportPublic FDA data

Application 050337

Type
NDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DYNAPENDICLOXACILLIN SODIUMFOR SUSPENSION;ORALEQ 62.5MG BASE/5MLNoNo

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
N050337-002DYNAPENDICLOXACILLIN SODIUMEQ 62.5MG BASE/5MLFOR SUSPENSION / ORALApproved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N050337-002DYNAPENEQ 62.5MG BASE/5MLFOR SUSPENSION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050337-002DYNAPENEQ 62.5MG BASE/5MLFOR SUSPENSION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050337-002DYNAPENEQ 62.5MG BASE/5MLFOR SUSPENSION / ORALApproved before 1982a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMRedpharm Drug58e6ee7a-8237-ec66-e063-6394a90a5cae2026-08-13Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
Dicloxacillin SodiumDICLOXACILLIN SODIUMPD-Rx Pharmaceuticals, Inc.c17cd62d-ff5d-47ba-8673-3346c7f2365f2026-05-21Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
Dicloxacillin SodiumDICLOXACILLIN SODIUMPD-Rx Pharmaceuticals, Inc.9e2bbe03-44cb-45d1-acdb-b61d9016055e2025-10-20Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
Dicloxacillin SodiumDICLOXACILLIN SODIUMPD-Rx Pharmaceuticals, Inc.24e821aa-85b8-4f5a-aa13-83ff132952ca2025-10-15Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
Dicloxacillin SodiumDICLOXACILLIN SODIUMBryant Ranch Prepack3e4842ec-773b-4aeb-b37d-1c4e3cf534242024-01-18Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMAurobindo Pharma Limited9074b5a6-850c-4144-9097-bb21073ee54d2023-12-27Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
Dicloxacillin SodiumDICLOXACILLIN SODIUMTeva Pharmaceuticals USA, Inc.8478f242-c715-4984-ac1d-dc79dc28665e2022-06-22Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM
Dicloxacillin SodiumDICLOXACILLIN SODIUMAsclemed USA, Inc.a4174fda-68f7-4834-be58-dd6b167cf9f02020-11-14Warnings, Adverse reactionsName fallback
generic name: DICLOXACILLIN SODIUM

Reported adverse events (FAERS/openFDA)#

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