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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Farmers Insurance
Harvard Business School
Novartis
Chinese Patent Office
Covington
Moodys
Accenture
US Army

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065500

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NDA 065500 describes AZITHROMYCIN, which is a drug marketed by Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-five NDAs. It is available from fifty-one suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065500
Tradename:AZITHROMYCIN
Applicant:Hospira
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065500
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065500
Suppliers and Packaging for NDA: 065500
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065500 ANDA Hospira, Inc. 0409-0144 N 0409-0144-11
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065500 ANDA Hospira, Inc. 0409-0144 N 0409-0144-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 26, 2009TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Medtronic
Boehringer Ingelheim
Harvard Business School
Express Scripts
Chubb
Fuji
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