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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 065515

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NDA 065515 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Qilu Pharm Hainan, Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pfizer, Pharmachemie Bv, Pharmobedient, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-seven NDAs. It is available from nine suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for 065515

Tradename:	DOXORUBICIN HYDROCHLORIDE
Applicant:	Almaject
Ingredient:	doxorubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065515

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Nov 8, 2012	TE:		RLD:	No

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