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Serving leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Cipla
Dow
Federal Trade Commission
US Army
Express Scripts
Cantor Fitzgerald
Medtronic
Chinese Patent Office

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065506

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NDA 065506 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 065506
Tradename:AZITHROMYCIN
Applicant:Mylan Asi
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065506
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065506
Suppliers and Packaging for NDA: 065506
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065506 ANDA Sagent Pharmaceuticals 25021-112 N 25021-112-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Mar 24, 2009TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Farmers Insurance
Fish and Richardson
Baxter
Chinese Patent Office
Accenture
Daiichi Sankyo
QuintilesIMS

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