Home Applications 020221 Application 020221
Type NDA
Sponsor CLINIGEN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ETHYOL AMIFOSTINE INJECTABLE;INJECTION 500MG/VIAL Yes Yes 002 ETHYOL AMIFOSTINE INJECTABLE;INJECTION 375MG/VIAL 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date N020221-001 ETHYOL AMIFOSTINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, RS 1995-12-08 N020221-002 ETHYOL AMIFOSTINE 375MG/VIAL INJECTABLE / INJECTION 1999-09-10
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 N020221-001 ETHYOL 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, RS 1995-12-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 a50c72e98297…
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 Ethyol AMIFOSTINE Legacy Pharma USA Inc. a17563f2-d231-4385-bc94-0217be78b89d 2026-03-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 020221 application number: NDA020221
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66220-017 Ethyol amifostine Cumberland Pharmaceuticals Inc. NDA Current 66220-017 Ethyol amifostine Cumberland Pharmaceuticals Inc. NDA Current 66220-017 Ethyol amifostine Cumberland Pharmaceuticals Inc. NDA Current 76310-017 Ethyol amifostine Clinigen Group PLC NDA Current 76310-017 Ethyol amifostine Clinigen Group PLC NDA Current 76310-017 Ethyol amifostine Clinigen Limited NDA Current