FDA.reportPublic FDA data

Application 219131

Type
NDA
Sponsor
ALMATICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 80MG BASEYesYes
002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 90MG BASEYesNo
003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 120MG BASEYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219131-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE, DELAYED REL PELLETS / ORALRLD, RS2026-02-27
N219131-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 90MG BASECAPSULE, DELAYED REL PELLETS / ORALRLD2026-02-27
N219131-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 120MG BASECAPSULE, DELAYED REL PELLETS / ORALRLD2026-02-27

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 ZIP2026-06N219131-001DULOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE, DELAYED REL PELLETS / ORALRLD, RS2026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219131-002DULOXETINE HYDROCHLORIDEEQ 90MG BASECAPSULE, DELAYED REL PELLETS / ORALRLD2026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219131-003DULOXETINE HYDROCHLORIDEEQ 120MG BASECAPSULE, DELAYED REL PELLETS / ORALRLD2026-02-27a50c72e98297…

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
DuloxetineDULOXETINEAlmatica Pharma LLCbb2ca3bf-983c-1e4a-a91d-dc7dee66d7412026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219131
application number: NDA219131

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85218ORIG 2026-03-03