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Serving leading biopharmaceutical companies globally:

Julphar
Argus Health
McKinsey
Express Scripts
US Army
US Department of Justice
Chubb
Cerilliant
McKesson
Covington

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065265

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NDA 065265 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 065265
Tradename:AZITHROMYCIN
Applicant:Cspc Ouyi Pharm Co
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065265
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065265
Suppliers and Packaging for NDA: 065265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065265 ANDA Cardinal Health 55154-5759 E 55154-5759-5

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 18, 2007TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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McKesson
Dow
Moodys
Queensland Health
Cerilliant
Medtronic
Accenture

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