Viewing data from:

DOXORUBICIN HYDROCHLORIDE

NDA

DOXORUBICIN HYDROCHLORIDE | N050629 | PFIZER INC

3 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

11 letters from Drugs@FDA

Date	Submission	Document
May 15, 2024	SUPPL -33	View Letter (PDF)
Aug 31, 2020	SUPPL -30	View Letter (PDF)
Dec 26, 2019	SUPPL -28	View Letter (PDF)
Aug 12, 2019	SUPPL -29	View Letter (PDF)
Nov 6, 2013	SUPPL -22	View Letter (PDF)
Sep 29, 2011	SUPPL -19	View Letter (PDF)
Aug 9, 2010	SUPPL -17	View Letter (PDF)
May 30, 2003	SUPPL -16	View Letter (PDF)
May 30, 2003	SUPPL -14	View Letter (PDF)
Sep 25, 2002	SUPPL -10	View Letter (PDF)
Sep 25, 2002	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2MG/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 23, 1987

No patent or exclusivity listings for this strength.

#002 — 200MG/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 3, 1988

#003 — 150MG/75ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 28, 2011