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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 065034

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NDA 065034 describes DAUNORUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the DAUNORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

Summary for 065034

Tradename:	DAUNORUBICIN HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	daunorubicin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/VIAL
Approval Date:	Nov 20, 2001	TE:		RLD:	No

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