FDA.reportPublic FDA data

Application 218820

Type
NDA
Sponsor
NEUROCRINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRENESSITYCRINECERFONTSOLUTION;ORAL50MG/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
N218820-001CRENESSITYCRINECERFONT50MG/MLSOLUTION / ORALRLD, RS2024-12-13

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218820-001109056902035-01-21U-40492025-01-10
N218820-001113115442035-01-21U-40492025-01-10
N218820-001117307392035-01-21U-40492025-01-10
N218820-001121280332041-06-09U-4049Drug substance2025-01-10
N218820-001125826342043-01-12Drug substance2026-04-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218820-001NCE2029-12-13
N218820-001ODE-5032031-12-13

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 22:38:342026-08N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-1384e616aacf4f…
2026-08-18 06:07:402026-07N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-1303ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001CRENESSITY50MG/MLSOLUTION / ORALRLD, RS2024-12-13a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218820-001109056902035-01-21U-40492025-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N218820-001113115442035-01-21U-40492025-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N218820-001117307392035-01-21U-40492025-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N218820-001121280332041-06-09U-4049Drug substance2025-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N218820-001125826342043-01-12Drug substance2026-04-2184e616aacf4f…
2026-08-18 06:07:402026-07N218820-001109056902035-01-21U-40492025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N218820-001113115442035-01-21U-40492025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N218820-001117307392035-01-21U-40492025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N218820-001121280332041-06-09U-4049Drug substance2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N218820-001125826342043-01-12Drug substance2026-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218820-001109056902035-01-21U-40492025-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218820-001113115442035-01-21U-40492025-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218820-001117307392035-01-21U-40492025-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218820-001121280332041-06-09U-4049Drug substance2025-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001109056902035-01-21U-40492025-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001113115442035-01-21U-40492025-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001117307392035-01-21U-40492025-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001121280332041-06-09U-4049Drug substance2025-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N218820-001109056902035-01-21U-40492025-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218820-001113115442035-01-21U-40492025-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218820-001117307392035-01-21U-40492025-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218820-001121280332041-06-09U-4049Drug substance2025-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001109056902035-01-21U-40492025-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001113115442035-01-21U-40492025-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001117307392035-01-21U-40492025-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001121280332041-06-09U-4049Drug substance2025-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001109056902035-01-21U-40492025-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001113115442035-01-21U-40492025-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001117307392035-01-21U-40492025-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001121280332041-06-09U-4049Drug substance2025-01-10b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001109056902035-01-21U-40492025-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001113115442035-01-21U-40492025-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001117307392035-01-21U-40492025-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001121280332041-06-09U-4049Drug substance2025-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001125826342043-01-12Drug substance2026-04-21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218820-001NCE2029-12-1384e616aacf4f…
2026-09-14 22:38:342026-08N218820-001ODE-5032031-12-1384e616aacf4f…
2026-08-18 06:07:402026-07N218820-001NCE2029-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N218820-001ODE-5032031-12-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218820-001NCE2029-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218820-001ODE-5032031-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001NCE2029-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218820-001ODE-5032031-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N218820-001NCE2029-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218820-001ODE-5032031-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001NCE2029-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218820-001ODE-5032031-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001NCE2029-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218820-001ODE-5032031-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218820-001ODE-5032031-12-1303ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001NCE2029-12-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218820-001ODE-5032031-12-13a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80833ORIG 2025-01-10
80598ORIG 2024-12-16
80575ORIG 2024-12-13