FDA.reportPublic FDA data

Application 220089

Type
NDA
Sponsor
APHELION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PYLARIFY TRUVUPIFLUFOLASTAT F-18SOLUTION;INTRAVENOUS1mCi/mL-120mCi/mLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220089-001PYLARIFY TRUVUPIFLUFOLASTAT F-181mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-06

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220089-00184871292027-11-07Drug substance, Drug product2026-04-03
N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-03
N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-03
N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-03
N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-03
N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220089-001NCE2026-05-26

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
2026-09-14 22:38:342026-08N220089-001PYLARIFY TRUVU1mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-0684e616aacf4f…
2026-08-18 06:07:402026-07N220089-001PYLARIFY TRUVU1mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001PYLARIFY TRUVU1mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-06a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N220089-00184871292027-11-07Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-08-18 06:07:402026-07N220089-00184871292027-11-07Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-00184871292027-11-07Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-03a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N220089-001NCE2026-05-2684e616aacf4f…
2026-08-18 06:07:402026-07N220089-001NCE2026-05-26caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001NCE2026-05-26a50c72e98297…

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
PYLARIFY TRUVUPIFLUFOLASTAT F-18Aphelion LLC121c1cb8-6f60-4644-a775-b81c6f21d8122026-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 220089
application number: NDA220089

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85363ORIG 2026-03-12