Home Applications 218615 Application 218615
Type ANDA
Sponsor EUGIA PHARMA 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 42 .
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 A218615-001 SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 A218615-002 SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 A218615-003 SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 A218615-004 SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14
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.
Product history page 1 of 2 · 64 observed 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 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218615-001 SUNITINIB MALATE EQ 12.5MG BASE CAPSULE / ORAL AB 2024-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218615-002 SUNITINIB MALATE EQ 25MG BASE CAPSULE / ORAL AB 2024-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218615-003 SUNITINIB MALATE EQ 37.5MG BASE CAPSULE / ORAL AB 2024-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218615-004 SUNITINIB MALATE EQ 50MG BASE CAPSULE / ORAL AB 2024-03-14 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
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.