Home Applications 219943 Application 219943
Type NDA
Sponsor ASTRAZENECA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KOSELUGO SELUMETINIB SULFATE GRANULE;ORAL EQ 5MG BASE Yes No 002 KOSELUGO SELUMETINIB SULFATE GRANULE;ORAL EQ 7.5MG BASE Yes Yes 003 KOSELUGO SELUMETINIB CAPSULE; ORAL 10MG No No 004 KOSELUGO SELUMETINIB CAPSULE; ORAL 25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219943-001 KOSELUGO SELUMETINIB SULFATE EQ 5MG BASE GRANULE / ORAL RLD, RS 2025-09-10 N219943-002 KOSELUGO SELUMETINIB SULFATE EQ 7.5MG BASE GRANULE / ORAL RLD 2025-09-10
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219943-001 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 N219943-001 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 N219943-001 9562017 2026-12-12 U-4357 Drug substance 2025-09-30 N219943-001 7425637 2028-03-13 Drug substance 2025-09-30 N219943-002 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 N219943-002 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 N219943-002 9562017 2026-12-12 U-4357 Drug substance 2025-09-30 N219943-002 7425637 2028-03-13 Drug substance 2025-09-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
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 2026-02-19 14:30 UTC 2026-02 N219943-001 KOSELUGO EQ 5MG BASE GRANULE / ORAL RLD 2025-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-002 KOSELUGO EQ 7.5MG BASE GRANULE / ORAL RLD, RS 2025-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-001 KOSELUGO EQ 5MG BASE GRANULE / ORAL RLD 2025-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-002 KOSELUGO EQ 7.5MG BASE GRANULE / ORAL RLD, RS 2025-09-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-001 KOSELUGO EQ 5MG BASE GRANULE / ORAL RLD, RS 2025-09-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-002 KOSELUGO EQ 7.5MG BASE GRANULE / ORAL RLD 2025-09-10 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 2026-02-19 14:30 UTC 2026-02 N219943-001 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-001 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-001 9562017 2026-12-12 U-4357 Drug substance 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-001 7425637 2028-03-13 Drug substance 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-002 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-002 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-002 9562017 2026-12-12 U-4357 Drug substance 2025-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219943-002 7425637 2028-03-13 Drug substance 2025-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-001 7425637 2026-03-13 Drug substance 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-001 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-001 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-001 9562017 2026-12-12 U-4274 Drug substance 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-002 7425637 2026-03-13 Drug substance 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-002 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-002 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219943-002 9562017 2026-12-12 U-4274 Drug substance 2025-09-30 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-001 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-001 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-001 9562017 2026-12-12 U-4357 Drug substance 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-001 7425637 2028-03-13 Drug substance 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-002 8178693 2026-03-13 Drug substance, Drug product 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-002 9156795 2026-12-12 Drug substance, Drug product 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-002 9562017 2026-12-12 U-4357 Drug substance 2025-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219943-002 7425637 2028-03-13 Drug substance 2025-09-30 a50c72e98297…
Observed Orange Book exclusivity history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KOSELUGO SELUMETINIB AstraZeneca Pharmaceuticals LP 7d042c61-f28f-4ab5-ab10-d7558c0d49ff 2026-05-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 219943 application number: NDA219943
Documents# Document, Submission type, Date table Document Submission type Date 84245 SUPPL 2025-11-21 84235 SUPPL 2025-11-20 83369 ORIG 2025-09-17 83368 ORIG 2025-09-17