Viewing data from:

DOXIL (LIPOSOMAL)

NDA

DOXORUBICIN HYDROCHLORIDE | N050718 | BAXTER HEALTHCARE CORP

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

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 Chain11 active DMFs2 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCDOXORUBICIN HYDROCHLORIDE

DMF 20981973

MEIJI SEIKA PHARMA CO LTDDOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE

DMF 132091998

MICROBIOPHARM JAPAN CO LTDDOXORUBICIN HYDROCHLORIDE

DMF 132111998

TAPI NL BVDOXORUBICIN HYDROCHLORIDE

DMF 137261998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE USP

DMF 137731998

SYNBIAS PHARMA AGDOXORUBICIN HYDROCHLORIDE

DMF 161782002

STERLING BIOTECH LTDDOXORUBICIN HYDROCHLORIDE(API)

DMF 248582011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE USP (FERMENTATION)

DMF 273112013

OLON SPADOXORUBICIN HYDROCHLORIDE

DMF 300352015

DZD (HEZE) PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE

DMF 311532016

INTAS PHARMACEUTICALS LTDDOXORUBICIN HYDROCHLORIDE USP

DMF 345452020

CHEMWERTH INCInactiveDOXORUBICIN HYDROCHLORIDE USP (NON-STERILE, BULK DRUG SUBSTANCE)

DMF 184622005

RPG LIFE SCIENCES LTDInactiveDOXORUBICIN HYDROCHLORIDE USP/EP

DMF 241282010

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Mar 12, 2026	SUPPL -64	View Letter (PDF)
May 9, 2022	SUPPL -60	View Letter (PDF)
Aug 13, 2019	SUPPL -55	View Letter (PDF)
Dec 29, 2015	SUPPL -50	View Letter (PDF)
Apr 17, 2015	SUPPL -48	View Letter (PDF)
Sep 4, 2013	SUPPL -45	View Letter (PDF)
Sep 24, 2012	SUPPL -43	View Letter (PDF)
Jun 13, 2008	SUPPL -33	View Letter (PDF)
May 29, 2007	SUPPL -28	View Letter (PDF)
May 29, 2007	SUPPL -29	View Letter (PDF)
Feb 3, 2005	SUPPL -20	View Letter (PDF)
Oct 29, 2004	SUPPL -19	View Letter (PDF)
Jun 2, 2004	SUPPL -10	View Letter (PDF)
Jun 28, 1999	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/10ML (2MG/ML)

RLDAB

0 patents0 exclusivities▴

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Nov 17, 1995

No patent or exclusivity listings for this strength.

#002 — 50MG/25ML (2MG/ML)

RLDAB

0 patents0 exclusivities▾

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Jun 13, 2000