Home Applications 218863 Application 218863
Type ANDA
Sponsor AMNEAL 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 42 .
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 A218863-001 EVEROLIMUS EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 A218863-002 EVEROLIMUS EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 A218863-003 EVEROLIMUS EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10
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 2026-08-18 06:07:40 2026-07 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218863-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218863-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218863-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-10 a50c72e98297…
Observed Orange Book normalized TE 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 EVEROLIMUS EVEROLIMUS Amneal Pharmaceuticals NY LLC 6f1ae129-c21e-4c25-84c1-a6757d9a7eb2 2026-06-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 218863 application number: ANDA218863