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Generated: November 13, 2018

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Details for New Drug Application (NDA): 203263

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NDA 203263 describes DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), which is a drug marketed by Dr Reddys Labs Ltd and Sun Pharma Global and is included in two NDAs. It is available from four suppliers. 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. Fifteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 203263
Tradename:DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Applicant:Sun Pharma Global
Ingredient:doxorubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203263
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 203263
Suppliers and Packaging for NDA: 203263
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 203263 ANDA Sun Pharmaceutical Industries, Inc. 47335-049 47335-049-40 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-049-40) > 10 mL in 1 VIAL, SINGLE-DOSE
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 203263 ANDA Sun Pharmaceutical Industries, Inc. 47335-050 47335-050-40 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-050-40) > 25 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:Feb 4, 2013TE:ABRLD:No

Profile 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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