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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 065000

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NDA 065000 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 065000

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 20MG BASE/VIAL
Approval Date:	May 25, 1999	TE:	AP	RLD:	No

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