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DAUNORUBICIN HYDROCHLORIDE

NDA

DAUNORUBICIN HYDROCHLORIDE | N050731 | HIKMA PHARMACEUTICALS USA 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 DMFs3 inactive

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

MICROBIOPHARM JAPAN CO LTDDAUNORUBICIN HYDROCHLORIDE (CRUDE)

DMF 118791996

MEIJI SEIKA PHARMA CO LTDDAUNORUBICIN HYDROCHLORIDE (DRUG SUBSTANCE)

DMF 137271998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDAUNORUBICIN HYDROCHLORIDE USP

DMF 137751998

TAPI NL BVDAUNORUBICIN HYDROCHLORIDE

DMF 137861998

OLON SPADAUNORUBICIN HYDROCHLORIDE

DMF 304252016

DZD (HEZE) PHARMACEUTICAL CO LTDDAUNORUBICIN HYDROCHLORIDE

DMF 311502016

SHANDONG NEW TIME PHARMACEUTICAL CO LTDDAUNORUBICIN HYDROCHLORIDE

DMF 386252023

HAIMEN PHARM FACTORYInactiveDAUNORUBICIN HYDROCHLORIDE

DMF 88291990

RHONE POULENC RORER PHARMACEUTICALS INCInactiveDAUNORUBICIN HYDROCHLORIDE

DMF 135031998

CHEMWERTH INCInactiveDAUNORUBICIN HYDROCHLORIDE (TECHNICAL GRADE)

DMF 172182004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 1, 2018	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5MG BASE/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 30, 1998

No patent or exclusivity listings for this strength.