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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 065035

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NDA 065035 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 two 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. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

Summary for 065035

Tradename:	DAUNORUBICIN HYDROCHLORIDE
Applicant:	Meitheal
Ingredient:	daunorubicin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Jan 24, 2000	TE:	AP	RLD:	No

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