FDA.reportPublic FDA data

Application 220406

Type
NDA
Sponsor
AVYXA HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYKOURALEUCOVORIN CALCIUMSOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 50MG BASE/5ML (EQ 10MG BASE/ML) YesYes
002VYKOURALEUCOVORIN CALCIUMSOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 350MG BASE/35ML (EQ 10MG BASE/ML)YesYes
003VYKOURALEUCOVORIN CALCIUMSOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/50ML (EQ 10MG 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
N220406-001VYKOURALEUCOVORIN CALCIUMEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03
N220406-002VYKOURALEUCOVORIN CALCIUMEQ 350MG BASE/35ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03
N220406-003VYKOURALEUCOVORIN CALCIUMEQ 500MG BASE/50ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220406-001125645922044-12-23Drug product2026-03-05
N220406-002125645922044-12-23Drug product2026-03-05
N220406-003125645922044-12-23Drug product2026-03-05

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 ZIP2026-06N220406-001VYKOURAEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-002VYKOURAEQ 350MG BASE/35ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-003VYKOURAEQ 500MG BASE/50ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-001125645922044-12-23Drug product2026-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-002125645922044-12-23Drug product2026-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-003125645922044-12-23Drug product2026-03-05a50c72e98297…

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
VYKOURALEUCOVORIN CALCIUMAvyxa Pharma, LLCd122b875-435e-4e00-b945-7a0546df95c22026-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 220406
application number: NDA220406

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84940ORIG 2026-02-05
84923ORIG 2026-02-05