Home Applications 215500 Application 215500
Type NDA
Sponsor USWM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IWILFIN EFLORNITHINE HYDROCHLORIDE TABLET;ORAL EQ 192MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N215500-001 IWILFIN EFLORNITHINE HYDROCHLORIDE EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13
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 N215500-001 12582625 2036-02-12 U-4444 2026-04-01
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215500-001 NP 2026-12-13 N215500-001 ODE-462 2030-12-13
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 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 2026-08-18 06:07:40 2026-07 N215500-001 12582625 2036-02-12 U-4444 2026-04-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215500-001 12582625 2036-02-12 U-4444 2026-04-01 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 iwilfin EFLORNITHINE HYDROCHLORIDE USWM, LLC 6716d8cc-66e6-4cee-935c-ccb85ed984f5 2026-03-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 215500 application number: NDA215500
Documents# Document, Submission type, Date table Document Submission type Date 80460 SUPPL 2024-12-02 80439 SUPPL 2024-11-29 78807 ORIG 2024-06-17 76822 ORIG 2023-12-14 76816 ORIG 2023-12-14