FDA.reportPublic FDA data

Application 219713

Type
NDA
Sponsor
NUVATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBTROZITALETRECTINIB ADIPATECAPSULE;ORALEQ 200MG BASEYesYes

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
N219713-001IBTROZITALETRECTINIB ADIPATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-11

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-27
N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-27

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219713-001NCE2030-06-11
N219713-001ODE-5442032-06-11

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 22:38:342026-08N219713-001IBTROZIEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-1184e616aacf4f…
2026-08-18 06:07:402026-07N219713-001IBTROZIEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219713-001IBTROZIEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219713-001IBTROZIEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N219713-001IBTROZIEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219713-001IBTROZIEQ 200MG BASECAPSULE / ORALRLD, RS2025-06-11a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-2784e616aacf4f…
2026-09-14 22:38:342026-08N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-2784e616aacf4f…
2026-08-18 06:07:402026-07N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-276a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219713-00191874892033-06-03U-4207Drug substance, Drug product2025-06-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219713-00197518872033-06-03U-4207Drug substance, Drug product2025-06-27a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219713-001NCE2030-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N219713-001ODE-5442032-06-1184e616aacf4f…
2026-08-18 06:07:402026-07N219713-001NCE2030-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N219713-001ODE-5442032-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219713-001NCE2030-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219713-001NCE2030-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N219713-001NCE2030-06-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219713-001NCE2030-06-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219713-001ODE-5442032-06-11a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82724ORIG 2025-07-02
82557ORIG 2025-06-12
82556ORIG 2025-06-12