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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203263

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NDA 203263 describes DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. 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. Thirteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for NDA: 203263

Formulation / Manufacturing:see details

Pharmacology for NDA: 203263

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 203263

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
doxorubicin hydrochloride
INJECTABLE, LIPOSOMAL;INJECTION 203263 ANDA Sun Pharma Global FZE 47335-049 47335-049-40 1 VIAL, SINGLE-USE in 1 PACKAGE (47335-049-40) > 10 mL in 1 VIAL, SINGLE-USE
doxorubicin hydrochloride
INJECTABLE, LIPOSOMAL;INJECTION 203263 ANDA Sun Pharma Global FZE 47335-050 47335-050-40 1 VIAL, SINGLE-USE in 1 PACKAGE (47335-050-40) > 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:Feb 4, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Feb 4, 2013TE:ABRLD:No

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