You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

Details for New Drug Application (NDA): 200170


✉ Email this page to a colleague

« Back to Dashboard


NDA 200170 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Norvium Bioscience, Pfizer, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-five NDAs. It is available from ten 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. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 200170
Tradename:DOXORUBICIN HYDROCHLORIDE
Applicant:Mylan Labs Ltd
Ingredient:doxorubicin hydrochloride
Patents:0
Pharmacology for NDA: 200170
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 200170
Suppliers and Packaging for NDA: 200170
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 200170 ANDA Mylan Institutional LLC 67457-436 67457-436-50 1 VIAL in 1 CARTON (67457-436-50) / 25 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Oct 28, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Oct 28, 2011TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.