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Last Updated: November 18, 2019

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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 two suppliers. 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 ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 050718
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:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:Nov 17, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Jun 13, 2000TE:ABRLD:Yes

Expired US Patents for NDA 050718

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

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