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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 050718

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NDA 050718 describes DOXIL (LIPOSOMAL), which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the DOXIL (LIPOSOMAL) profile page.

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

Summary for 050718

Tradename:	DOXIL (LIPOSOMAL)
Applicant:	Baxter Hlthcare Corp
Ingredient:	doxorubicin hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 050718

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 050718

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 050718

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718	NDA	Baxter Healthcare Corporation	0338-0063	0338-0063-01	1 VIAL, SINGLE-USE in 1 CARTON (0338-0063-01) / 10 mL in 1 VIAL, SINGLE-USE
DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718	NDA	Baxter Healthcare Corporation	0338-0067	0338-0067-01	1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	20MG/10ML (2MG/ML)
Approval Date:	Nov 17, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Jun 13, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050718

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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