Viewing data from:

EPIRUBICIN HYDROCHLORIDE

NDA

EPIRUBICIN HYDROCHLORIDE | N050807 | HOSPIRA 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

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 DMFs3 inactive

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

SYNBIAS PHARMA AGEPIRUBICIN HYDROCHLORIDE

DMF 162582002

TAPI NL BVEPIRUBICIN HYDROCHLORIDE LYOPHILIZED

DMF 183072005

SHANDONG NEW TIME PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 198182006

TAPI NL BVEPIRUBICIN HYDROCHLORIDE PRECIPITATED

DMF 213032008

MICROBIOPHARM JAPAN CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 220182008

DZD (HEZE) PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 313732017

SHANDONG NEW TIME PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE USP

DMF 380602023

FARMITALIA CARLO ERBA SPAInactiveEPIRUBICIN HYDROCHLORIDE

DMF 53591984

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveEPIRUBICIN HYDROCHLORIDE

DMF 163242002

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveEPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 184982005

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 15, 2006

No patent or exclusivity listings for this strength.

#002 — 200MG/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Sep 15, 2006