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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Novartis
Accenture
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065209

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NDA 065209 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 065209

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065209

Ingredient-typeMacrolides

Medical Subject Heading (MeSH) Categories for 065209

Suppliers and Packaging for NDA: 065209

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065209 ANDA Sandoz Inc 0781-1497 0781-1497-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-1497-31)
AZITHROMYCIN azithromycin TABLET;ORAL 065209 ANDA Sandoz Inc 0781-5793 0781-5793-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-5793-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE
Approval Date:Nov 14, 2005TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Covington
AstraZeneca
QuintilesIMS
Daiichi Sankyo
Fuji
US Department of Justice
Accenture
Mallinckrodt
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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