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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 063277


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NDA 063277 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pfizer, Pharmachemie Bv, Pharmobedient, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-six NDAs. It is available from nine suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 063277
Tradename:DOXORUBICIN HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:doxorubicin hydrochloride
Patents:0
Pharmacology for NDA: 063277
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 063277
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Suppliers and Packaging for NDA: 063277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063277 ANDA Fresenius Kabi USA, LLC 63323-101 63323-101-61 1 VIAL, MULTI-DOSE in 1 CARTON (63323-101-61) / 100 mL in 1 VIAL, MULTI-DOSE
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063277 ANDA Fresenius Kabi USA, LLC 63323-883 63323-883-05 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Oct 26, 1995TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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