Home Applications 022025 Application 022025
Type NDA
Sponsor CLINIGEN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOTECT DEXRAZOXANE HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022025-001 TOTECT DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2007-09-06
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 N022025-001 TOTECT EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2007-09-06 a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66220-110 Totect dexrazoxane hydrochloride Cumberland Pharmaceuticals Inc. NDA Current 66220-110 Totect dexrazoxane hydrochloride Cumberland Pharmaceuticals Inc. NDA Current 76310-110 Totect dexrazoxane hydrochloride CLINIGEN GROUP PLC NDA Current 76310-110 Totect dexrazoxane hydrochloride CLINIGEN GROUP PLC NDA Current 76310-110 Totect dexrazoxane hydrochloride CLINIGEN GROUP PLC NDA Current 76310-110 Totect dexrazoxane hydrochloride CLINIGEN GROUP PLC NDA Current 76310-110 Totect dexrazoxane hydrochloride Clinigen Limited NDA Current 76310-110 Totect dexrazoxane hydrochloride CLINIGEN GROUP PLC NDA Current