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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 208657


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NDA 208657 describes DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), which is a drug marketed by Dr Reddys Labs Ltd and Sun Pharm 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 208657
Tradename:DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Applicant:Dr Reddys Labs Ltd
Ingredient:doxorubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208657
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 208657
Suppliers and Packaging for NDA: 208657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 208657 ANDA NorthStar RxLLC 16714-742 16714-742-01 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-742-01) > 10 mL in 1 VIAL, SINGLE-DOSE
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 208657 ANDA NorthStar RxLLC 16714-856 16714-856-01 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-856-01) > 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:May 15, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:May 15, 2017TE:ABRLD:No

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