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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Chubb
Covington
Teva
Farmers Insurance
Accenture
Moodys
Boehringer Ingelheim
McKesson

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065511

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NDA 065511 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-two 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-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065511
Tradename:AZITHROMYCIN
Applicant:Hospira
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065511
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065511
Suppliers and Packaging for NDA: 065511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065511 ANDA Hospira, Inc. 0409-0144 0409-0144-11 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-0144-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065511 ANDA Hospira, Inc. 0409-0144 0409-0144-10 10 VIAL in 1 TRAY (0409-0144-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 26, 2009TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
UBS
Cipla
Healthtrust
Dow
Cerilliant
Colorcon
Citi
McKesson

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