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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207228

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NDA 207228 describes DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), which is a drug marketed by Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) profile page.

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

Summary for 207228

Tradename:	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Applicant:	Ayana Pharma Ltd
Ingredient:	doxorubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 207228

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	20MG/10ML (2MG/ML)
Approval Date:	Oct 12, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Oct 12, 2021	TE:	AB	RLD:	No

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