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Serving leading biopharmaceutical companies globally:

McKinsey
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065223

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NDA 065223 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 065223

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

Pharmacology for NDA: 065223

Ingredient-typeMacrolides

Medical Subject Heading (MeSH) Categories for 065223

Suppliers and Packaging for NDA: 065223

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065223 ANDA Teva Pharmaceuticals USA, Inc. 50111-788 50111-788-67 3 CARTON in 1 PACKAGE (50111-788-67) > 1 BLISTER PACK in 1 CARTON > 3 TABLET, FILM COATED in 1 BLISTER PACK
AZITHROMYCIN azithromycin TABLET;ORAL 065223 ANDA Teva Pharmaceuticals USA, Inc. 50111-788 50111-788-55 1 BLISTER PACK in 1 CARTON (50111-788-55) > 3 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Medtronic
Queensland Health
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Boehringer Ingelheim
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QuintilesIMS
Daiichi Sankyo
UBS

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