Home Applications 217759 Application 217759
Type NDA
Sponsor PHARMING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JOENJA LENIOLISIB PHOSPHATE TABLET;ORAL EQ 70MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217759-001 JOENJA LENIOLISIB PHOSPHATE EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217759-001 NCE 2028-03-24 N217759-001 ODE-430 2030-03-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N217759-001 NCE 2028-03-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N217759-001 ODE-430 2030-03-24 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Joenja LENIOLISIB Pharming Healthcare Inc. eefbcef8-2130-4654-8f29-b58077e08212 2025-06-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 217759 application number: NDA217759
Documents# Document, Submission type, Date table Document Submission type Date 82394 SUPPL 2025-06-02 82351 SUPPL 2025-05-29 74034 ORIG 2023-04-21 73873 ORIG 2023-03-27 73863 ORIG 2023-03-24