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ZINECARD

NDA

DEXRAZOXANE HYDROCHLORIDE | N020212 | PFIZER INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services Inc FDA-2021-P-1184 · 2 docket documents Lachman Consultant Services Inc filed this petition on behalf of a client requesting that the FDA Commissioner determine whether Zinecard (Dexrazoxane) for Injection in 250mg and 500mg base per vial strengths under NDA 020212 held by Pfizer Inc. was voluntarily withdrawn from commercial distribution	505(q)	2021-11-01	Open	Lachman Consultant Services Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

47 trials from ClinicalTrials.gov — 3 recruiting, 6 active, 23 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT03164057	Phase 2	Active	St. Jude Children's Research Hospital	206	2017-06-15 → 2027-06
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma NCT01864109	Phase 2	Active	Memorial Sloan Kettering Cancer Center	83	2013-05 → 2027-05
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma NCT00077285	Phase 2	Active	Memorial Sloan Kettering Cancer Center	65	2003-10 → 2027-10
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents NCT03020030	Phase 3	Active	Dana-Farber Cancer Institute	560	2017-03-03 → 2034-11
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy NCT01871766	Phase 2	Active	St. Jude Children's Research Hospital	115	2013-12-04 → 2030-06
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers NCT03589729	Phase 2	Recruiting	M.D. Anderson Cancer Center	100	2018-09-19 → 2027-12-31
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations NCT04293562	Phase 3	Recruiting	Children's Oncology Group	1,186	2020-07-21 → 2029-06-30
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)NCT03126916	Phase 3	Recruiting	Children's Oncology Group	750	2018-05-14 → 2030-09-30
Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors NCT00039481	Phase 1	Completed	National Cancer Institute (NCI)	15	2002-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain8 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

STERLING WISCONSIN LLCDEXRAZOXANE (FP-048)

DMF 183362005

TAPI NL BVDEXRAZOXANE (ICRF-187)

DMF 190022005

BIOCARE PHARMACEUTICAL LTDDEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCE

DMF 215422008

GLAND PHARMA LTDDEXRAZOXANE

DMF 231722009

GLAND PHARMA LTDDEXRAZOXANE (PROCESS-II)

DMF 278262014

MSN LABORATORIES PRIVATE LTDDEXRAZOXANE

DMF 346942020

APITORIA PHARMA PRIVATE LTDDEXRAZOXANE

DMF 377162022

PORTON PHARMA SOLUTIONS LTDDEXRAZOXANE

DMF 381862023

BOEHRINGER INGELHEIM CHEMICALS INCInactiveDEXRAZOXANE

DMF 151842000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 14, 2025	SUPPL -21	View Letter (PDF)
Apr 21, 2014	SUPPL -17	View Letter (PDF)
Jul 9, 2012	SUPPL -13	View Letter (PDF)
May 25, 2005	SUPPL -8	View Letter (PDF)
Oct 31, 2002	SUPPL -6	View Letter (PDF)
Oct 31, 2002	SUPPL -5	View Letter (PDF)
Oct 31, 2002	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 26, 1995

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 26, 1995