FDA.reportPublic FDA data

Application 219868

Type
NDA
Sponsor
AZURITY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERABRIGHTFERUMOXYTOLSOLUTION;INTRAVENOUSEQ 300MG IRON/10ML (EQ 30MG IRON/ML)YesYes
002FERABRIGHTFERUMOXYTOLSOLUTION;INTRAVENOUSEQ 510MG IRON/17ML (EQ 30MG IRON/ML)YesYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219868-001FERABRIGHTFERUMOXYTOLEQ 300MG IRON/10ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-16
N219868-002FERABRIGHTFERUMOXYTOLEQ 510MG IRON/17ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219868-001NP2028-10-16
N219868-002NP2028-10-16

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
2026-02-19 14:30 UTC2026-02N219868-001FERABRIGHTEQ 300MG IRON/10ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219868-002FERABRIGHTEQ 510MG IRON/17ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219868-001FERABRIGHTEQ 300MG IRON/10ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219868-002FERABRIGHTEQ 510MG IRON/17ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-1631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219868-001FERABRIGHTEQ 300MG IRON/10ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219868-002FERABRIGHTEQ 510MG IRON/17ML (EQ 30MG IRON/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-16a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N219868-001NP2028-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219868-002NP2028-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219868-001NP2028-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219868-002NP2028-10-1631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219868-001NP2028-10-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219868-002NP2028-10-16a50c72e98297…

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
FeraBrightFERUMOXYTOLAzurity Pharmaceuticals, Inc.ac666008-a14f-43b4-9d06-ec70f45a42342025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219868
application number: NDA219868

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83838ORIG 2025-10-21
83810ORIG 2025-10-20