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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Novartis
Dow
Julphar
Johnson and Johnson
Accenture
Fuji
QuintilesIMS
Chinese Patent Office

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065509

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NDA 065509 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 065509
Tradename:AZITHROMYCIN
Applicant:Apotex Corp
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065509
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065509
Suppliers and Packaging for NDA: 065509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065509 ANDA PD-Rx Pharmaceuticals, Inc. 43063-506 43063-506-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-506-03)
AZITHROMYCIN azithromycin TABLET;ORAL 065509 ANDA PD-Rx Pharmaceuticals, Inc. 43063-506 43063-506-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-506-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jul 13, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Farmers Insurance
Daiichi Sankyo
Teva
Federal Trade Commission
Cipla
Medtronic
Merck

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