FDA.reportPublic FDA data

Application 217759

Type
NDA
Sponsor
PHARMING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JOENJALENIOLISIB PHOSPHATETABLET;ORALEQ 70MG 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
N217759-001JOENJALENIOLISIB PHOSPHATEEQ 70MG BASETABLET / ORALRLD, RS2023-03-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217759-00186530922032-02-19Drug substance, Drug product2023-04-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217759-001NCE2028-03-24
N217759-001ODE-4302030-03-24

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 22:38:342026-08N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-2484e616aacf4f…
2026-08-18 06:07:402026-07N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-248072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217759-00186530922032-02-19Drug substance, Drug product2023-04-1884e616aacf4f…
2026-08-18 06:07:402026-07N217759-00186530922032-02-19Drug substance, Drug product2023-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217759-00186530922032-02-19Drug substance, Drug product2023-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217759-00186530922032-02-19Drug substance, Drug product2023-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N217759-00186530922032-02-19Drug substance, Drug product2023-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217759-00186530922032-02-19Drug substance, Drug product2023-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217759-00186530922032-02-19Drug substance, Drug product2023-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217759-00186530922032-02-19Drug substance, Drug product2023-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217759-00186530922032-02-19Drug substance, Drug product2023-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217759-00186530922032-02-19Drug substance, Drug product2023-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217759-00186530922032-02-19Drug substance, Drug product2023-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217759-00186530922032-02-19Drug substance, Drug product2023-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217759-00186530922032-02-19Drug substance, Drug product2023-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217759-00186530922032-02-19Drug substance, Drug product2023-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217759-00186530922032-02-19Drug substance, Drug product2023-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217759-00186530922032-02-19Drug substance, Drug product2023-04-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217759-00186530922032-02-19Drug substance, Drug product2023-04-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217759-00186530922032-02-19Drug substance, Drug product2023-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217759-00186530922032-02-19Drug substance, Drug product2023-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217759-00186530922032-02-19Drug substance, Drug product2023-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217759-00186530922032-02-19Drug substance, Drug product2023-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N217759-00186530922032-02-19Drug substance, Drug product2023-04-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N217759-00186530922032-02-19Drug substance, Drug product2023-04-183f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217759-00186530922032-02-19Drug substance, Drug product2023-04-18a50c72e98297…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217759-001NCE2028-03-2484e616aacf4f…
2026-09-14 22:38:342026-08N217759-001ODE-4302030-03-2484e616aacf4f…
2026-08-18 06:07:402026-07N217759-001NCE2028-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N217759-001ODE-4302030-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217759-001NCE2028-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217759-001ODE-4302030-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217759-001NCE2028-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217759-001ODE-4302030-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217759-001NCE2028-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217759-001ODE-4302030-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217759-001NCE2028-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217759-001ODE-4302030-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217759-001NCE2028-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217759-001ODE-4302030-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217759-001NCE2028-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217759-001ODE-4302030-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217759-001NCE2028-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217759-001ODE-4302030-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217759-001NCE2028-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217759-001ODE-4302030-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217759-001NCE2028-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217759-001ODE-4302030-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217759-001NCE2028-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N217759-001ODE-4302030-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217759-001NCE2028-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217759-001ODE-4302030-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217759-001NCE2028-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217759-001ODE-4302030-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217759-001NCE2028-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217759-001ODE-4302030-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217759-001NCE2028-03-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N217759-001ODE-4302030-03-248072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217759-001NCE2028-03-246a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217759-001ODE-4302030-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217759-001NCE2028-03-241c564ffb4f44…
2024-02-18 07:12 UTC2024-02N217759-001ODE-4302030-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217759-001NCE2028-03-24ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N217759-001ODE-4302030-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217759-001NCE2028-03-24a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217759-001ODE-4302030-03-24a72a2bbeb626…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82394SUPPL 2025-06-02
82351SUPPL 2025-05-29
74034ORIG 2023-04-21
73873ORIG 2023-03-27
73863ORIG 2023-03-24