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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs1 inactive

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

STERLING WISCONSIN LLCDEXRAZOXANE (FP-048)

DMF 183362005

TAPI NL BVDEXRAZOXANE (ICRF-187)

DMF 190022005

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#001 — EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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#002 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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