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Generated: November 25, 2017

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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 three 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. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for 203263

Tradename:
1
Applicant:
1
Ingredient:
1
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 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 (LIPOSOMAL)
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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