Application 220092

Type
NDA
Sponsor
JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREZCOBIX PEDCOBICISTAT; DARUNAVIR ETHANOLATETABLET, FOR SUSPENSION;ORAL90MG;EQ 600MG BASEYesYes
002PREZCOBIXDARUNAVIR AND COBICISTATTABLET, FOR SUSPENSION;ORAL675MG/150MGNoNo
003PREZCOBIXDARUNAVIR AND COBICISTATTABLET, FOR SUSPENSION;ORAL600MG/90MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N220092-001PREZCOBIX PEDCOBICISTAT; DARUNAVIR ETHANOLATE90MG;EQ 600MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2026-02-27

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220092-001PREZCOBIX PED90MG;EQ 600MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2026-02-27a50c72e98297…

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
PREZCOBIXDARUNAVIR ETHANOLATE AND COBICISTATJanssen Products, LP9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f2026-02-01Warnings, Adverse reactionsName fallback
brand name: PREZCOBIX PED

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85220ORIG 2026-03-03