Home Applications 218171 Application 218171
Type NDA
Sponsor XCOVERY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENSACOVE ENSARTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Yes No 002 ENSACOVE ENSARTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N218171-001 ENSACOVE ENSARTINIB HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 N218171-002 ENSACOVE ENSARTINIB HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18
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 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218171-001 NCE 2029-12-18 N218171-002 NCE 2029-12-18
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 2026-10-15 13:18:30 2026-09 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 31067a03dcf5…
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 ENSACOVE ENSARTINIB Xcovery Holdings, Inc. 1e1b2f79-678a-472a-b924-66909c8a4b2e 2026-02-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 218171 application number: NDA218171
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 85193 SUPPL 2026-03-02 85192 SUPPL 2026-03-02 84734 SUPPL 2026-01-12 84725 SUPPL 2026-01-09 80855 ORIG 2025-01-16 80647 ORIG 2024-12-19 80629 ORIG 2024-12-19