Home Applications 020212 Application 020212
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZINECARD DEXRAZOXANE HYDROCHLORIDE INJECTABLE;INJECTION EQ 250MG BASE/VIAL Yes Yes 002 ZINECARD 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020212-001 ZINECARD DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-05-26 N020212-002 ZINECARD DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-05-26
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 N020212-001 ZINECARD EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-05-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N020212-002 ZINECARD EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-05-26 a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0013-8717 Zinecard dexrazoxane Pharmacia and Upjohn Company LLC NDA Current 0013-8717 Zinecard dexrazoxane Pharmacia and Upjohn Company LLC NDA Current 0013-8727 Zinecard dexrazoxane Pharmacia and Upjohn Company LLC NDA Current