Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Merck
Argus Health
Citi
Covington
Boehringer Ingelheim
Teva
Moodys
Julphar
Farmers Insurance

Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091599

« Back to Dashboard
NDA 091599 describes EPIRUBICIN HYDROCHLORIDE, which is a drug marketed by Hospira, Fresenius Kabi Usa, Fresenius Kabi Oncol, Impax Labs Inc, Ebewe Pharma, Actavis Totowa, Cipla Ltd, Akorn Inc, Mustafa Nevsat, Mylan Institutional, Hisun Pharm Hangzhou, West-ward Pharms Int, and Mylan Labs Ltd, and is included in fourteen NDAs. It is available from ten suppliers. Additional details are available on the EPIRUBICIN HYDROCHLORIDE profile page.

The generic ingredient in EPIRUBICIN HYDROCHLORIDE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for NDA: 091599

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091599

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 091599

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 091599 ANDA Amneal-Agila, LLC 53150-247 53150-247-01 1 VIAL, GLASS in 1 CARTON (53150-247-01) > 100 mL in 1 VIAL, GLASS
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 091599 ANDA Amneal-Agila, LLC 53150-250 53150-250-01 1 VIAL, GLASS in 1 CARTON (53150-250-01) > 25 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Mar 12, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Mar 12, 2012TE:APRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Deloitte
Citi
Argus Health
McKesson
Cerilliant
Farmers Insurance
Daiichi Sankyo
AstraZeneca
McKinsey

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot