Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212219

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NDA 212219 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for 212219

Tradename:	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Applicant:	Baxter Hlthcare Corp
Ingredient:	doxorubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 212219

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 19, 2022	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 19, 2022	TE:	AB	RLD:	No

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