Home Applications 218012 Application 218012
Type ANDA
Sponsor FOSUN WANBANG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE No No 002 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE No No 003 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE No No 004 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218012-001 SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2023-08-21 A218012-002 SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 A218012-003 SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2023-08-21 A218012-004 SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-08-01 22:54:32 2026-06 A218012-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2023-08-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A218012-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A218012-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2023-08-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A218012-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 a50c72e98297…
Observed Orange Book normalized TE history# 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.