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Serving leading biopharmaceutical companies globally:

US Army
AstraZeneca
UBS
Healthtrust
Johnson and Johnson
Express Scripts
Merck
Fuji
Covington
McKinsey

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203294

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NDA 203294 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 203294

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

Pharmacology for NDA: 203294

Ingredient-typeMacrolides

Medical Subject Heading (MeSH) Categories for 203294

Suppliers and Packaging for NDA: 203294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 203294 ANDA AuroMedics Pharma LLC 55150-174 55150-174-10 10 VIAL in 1 CARTON (55150-174-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 19, 2015TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Accenture
Boehringer Ingelheim
Healthtrust
Johnson and Johnson
Merck
Argus Health
AstraZeneca
Harvard Business School

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