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Serving leading biopharmaceutical companies globally:

Covington
Dow
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Daiichi Sankyo
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Chinese Patent Office
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065193

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NDA 065193 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 Labs Ltd, Sagent Strides, 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 065193
Tradename:AZITHROMYCIN
Applicant:Teva
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065193
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065193
Suppliers and Packaging for NDA: 065193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065193 ANDA Teva Pharmaceuticals USA, Inc. 0093-7169 0093-7169-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7169-56)
AZITHROMYCIN azithromycin TABLET;ORAL 065193 ANDA REMEDYREPACK INC. 70518-0225 70518-0225-2 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0225-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Nov 14, 2005TE:ABRLD:No

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Medtronic
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Colorcon
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Queensland Health
US Department of Justice
QuintilesIMS
Cipla

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