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Last Updated: April 1, 2026

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 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 065035

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

Pharmacology for NDA: 065035

Mechanism of Action	Topoisomerase Inhibitors

Suppliers and Packaging for NDA: 065035

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	065035	ANDA	Meitheal Pharmaceuticals Inc.	71288-182	71288-182-05	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04)

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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