.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Fuji
Julphar
Cerilliant
Argus Health
Queensland Health
Cipla
UBS
McKinsey
Moodys

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065035

« Back to Dashboard
NDA 065035 describes DAUNORUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Teva Parenteral, West-ward Pharms Int, and Teva Pharms Usa, and is included in five NDAs. It is available from one supplier. Additional details are available on the DAUNORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

Summary for NDA: 065035

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

Pharmacology for NDA: 065035

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065035

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAUNORUBICIN HYDROCHLORIDE
daunorubicin hydrochloride
INJECTABLE;INJECTION 065035 ANDA Teva Parenteral Medicines, Inc. 0703-5233 0703-5233-13 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-5233-13) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-5233-11)
DAUNORUBICIN HYDROCHLORIDE
daunorubicin hydrochloride
INJECTABLE;INJECTION 065035 ANDA Teva Parenteral Medicines, Inc. 0703-5233 0703-5233-93 10 VIAL, SINGLE-DOSE in 1 TRAY (0703-5233-93) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-5233-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jan 24, 2000TE: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:

Daiichi Sankyo
Express Scripts
Colorcon
Federal Trade Commission
Cerilliant
Farmers Insurance
Chubb
Teva
QuintilesIMS
UBS

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