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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 200901

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NDA 200901 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Norvium Bioscience, Pfizer, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-five NDAs. It is available from ten 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. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for 200901

Tradename:	DOXORUBICIN HYDROCHLORIDE
Applicant:	Norvium Bioscience
Ingredient:	doxorubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 200901

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Feb 14, 2012	TE:		RLD:	No

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