.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► 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:

Harvard Business School
Johnson and Johnson
Julphar
US Department of Justice
UBS
Covington
McKinsey
Fuji
Federal Trade Commission
Citi

Generated: June 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065511

« Back to Dashboard
NDA 065511 describes AZITHROMYCIN, which is a drug marketed by Hospira, Lupin Ltd, Gland Pharma Ltd, Wockhardt, Sagent Strides, Apotex Corp, Teva Parenteral, Sandoz, Pliva, Teva Pharms, Sun Pharm Inds Ltd, Mylan Labs Ltd, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in thirty-five NDAs. It is available from forty-eight suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for NDA: 065511

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065511

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 065511

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
INJECTABLE;INJECTION 065511 ANDA Hospira, Inc. 0409-0144 0409-0144-11 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-0144-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM
AZITHROMYCIN
azithromycin
INJECTABLE;INJECTION 065511 ANDA Hospira, Inc. 0409-0144 0409-0144-10 10 VIAL in 1 TRAY (0409-0144-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 26, 2009TE: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:

Fish and Richardson
Argus Health
Novartis
Accenture
Chinese Patent Office
Fuji
Harvard Business School
QuintilesIMS
US Department of Justice
Merck

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

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot