FDA.reportPublic FDA data

Application 219920

Type
NDA
Sponsor
AVYXA HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVGEMSIGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)YesNo
002AVGEMSIGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)YesYes
003AVGEMSIGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)YesYes

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
N219920-001AVGEMSIGEMCITABINE HYDROCHLORIDEEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-06-27
N219920-002AVGEMSIGEMCITABINE HYDROCHLORIDEEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-27
N219920-003AVGEMSIGEMCITABINE HYDROCHLORIDEEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-27

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
2026-02-19 14:30 UTC2026-02N219920-001AVGEMSIEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219920-002AVGEMSIEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219920-003AVGEMSIEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219920-001AVGEMSIEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219920-002AVGEMSIEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219920-003AVGEMSIEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N219920-001AVGEMSIEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219920-002AVGEMSIEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219920-003AVGEMSIEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-276a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219920-001AVGEMSIEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-06-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219920-002AVGEMSIEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219920-003AVGEMSIEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-27a50c72e98297…

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
AVGEMSIGEMCITABINEAvyxa Pharma, LLCe11eeff7-bcaf-4bf1-8da8-88138e01af842026-07-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 219920
application number: NDA219920

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82696ORIG 2026-03-03
82697ORIG 2025-06-30