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TOTECT

NDA

DEXRAZOXANE HYDROCHLORIDE | N022025 | CLINIGEN INC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: Sep 6, 2007

No patent or exclusivity listings for this strength.