Home Applications 218472 Application 218472
Type ANDA
Sponsor HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 NINTEDANIB NINTEDANIB CAPSULE 100MG No No 003 NINTEDANIB NINTEDANIB CAPSULE 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 A218472-001 NINTEDANIB ESYLATE NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-07-09 A218472-002 NINTEDANIB ESYLATE NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218472-001 NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-07-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218472-002 NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-07-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218472-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218472-002 AB 1 a50c72e98297…
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.