FDA.reportPublic FDA data

Application 219921

Type
NDA
Sponsor
AVYXA HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYXATACARBOPLATINSOLUTION;INTRAVENOUS20MG/2ML (10MG/ML)YesNo
002KYXATACARBOPLATINSOLUTION;INTRAVENOUS80MG/8ML (10MG/ML)YesYes
003KYXATACARBOPLATINSOLUTION;INTRAVENOUS500MG/50ML (10MG/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
N219921-001KYXATACARBOPLATIN20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2025-08-08
N219921-002KYXATACARBOPLATIN80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-08
N219921-003KYXATACARBOPLATIN500MG/50ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219921-001124271042045-04-01Drug product2025-10-02
N219921-002124271042045-04-01Drug product2025-10-02
N219921-003124271042045-04-01Drug product2025-10-02

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 UTC2026-02N219921-001KYXATA20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2025-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219921-002KYXATA80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219921-003KYXATA500MG/50ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219921-001KYXATA20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2025-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219921-002KYXATA80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219921-003KYXATA500MG/50ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-0831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219921-001KYXATA20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2025-08-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219921-002KYXATA80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219921-003KYXATA500MG/50ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-08-08a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219921-001124271042045-04-01Drug product2025-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219921-002124271042045-04-01Drug product2025-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219921-003124271042045-04-01Drug product2025-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219921-001124271042045-04-01Drug product2025-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219921-002124271042045-04-01Drug product2025-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219921-003124271042045-04-01Drug product2025-10-0231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219921-001124271042045-04-01Drug product2025-10-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219921-002124271042045-04-01Drug product2025-10-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219921-003124271042045-04-01Drug product2025-10-02a50c72e98297…

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
KYXATACARBOPLATINAvyxa Pharma, LLCf91c48da-68d1-4aa7-89b8-d84a3e8b629b2025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219921
application number: NDA219921

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83092ORIG 2025-08-12
83069ORIG 2025-08-11