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Express Scripts
Covington
US Department of Justice
Daiichi Sankyo
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Cerilliant
Deloitte
Farmers Insurance
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203294

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NDA 203294 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 203294
Tradename:AZITHROMYCIN
Applicant:Aurobindo Pharma Ltd
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203294
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 203294
Suppliers and Packaging for NDA: 203294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 203294 ANDA AuroMedics Pharma LLC 55150-174 N 55150-174-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 19, 2015TE:APRLD:No

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