Home Applications 217640 Application 217640
Type ANDA
Sponsor NATCO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EVEROLIMUS EVEROLIMUS TABLET, FOR SUSPENSION;ORAL 2MG No No 002 EVEROLIMUS EVEROLIMUS TABLET, FOR SUSPENSION;ORAL 3MG No No 003 EVEROLIMUS EVEROLIMUS TABLET, FOR SUSPENSION;ORAL 5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217640-001 EVEROLIMUS EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 A217640-002 EVEROLIMUS EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 A217640-003 EVEROLIMUS EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Everolimus EVEROLIMUS Breckenridge Pharmaceutical, Inc. 01f7b5fb-be0d-4adf-acd2-6899018de966 2025-09-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 217640 application number: ANDA217640