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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 Janssen Res And Dev 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 sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for NDA: 050718

Tradename:
DOXIL (LIPOSOMAL)
Applicant:
Janssen Res And Dev
Ingredient:
doxorubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050718

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase 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 Janssen Products, LP 59676-960 59676-960-01 1 VIAL, SINGLE-USE in 1 CARTON (59676-960-01) > 10 mL in 1 VIAL, SINGLE-USE
DOXIL (LIPOSOMAL)
doxorubicin hydrochloride
INJECTABLE, LIPOSOMAL;INJECTION 050718 NDA Janssen Products, LP 59676-960 59676-960-02 1 VIAL, SINGLE-USE in 1 CARTON (59676-960-02) > 25 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:Nov 17, 1995TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Jun 13, 2000TE:ABRLD:No

Expired Orange Book Patents for NDA: 050718

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And Dev
DOXIL (LIPOSOMAL)
doxorubicin hydrochloride
INJECTABLE, LIPOSOMAL;INJECTION050718-001Nov 17, 19955,013,556► subscribe
Janssen Res And Dev
DOXIL (LIPOSOMAL)
doxorubicin hydrochloride
INJECTABLE, LIPOSOMAL;INJECTION050718-002Jun 13, 20005,213,804► subscribe
Janssen Res And Dev
DOXIL (LIPOSOMAL)
doxorubicin hydrochloride
INJECTABLE, LIPOSOMAL;INJECTION050718-002Jun 13, 20005,013,556► subscribe
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