BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim
McKinsey
Moodys
QuintilesIMS
UBS
Cipla
Healthtrust

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065179

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NDA 065179 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 065179
Tradename:AZITHROMYCIN
Applicant:Fresenius Kabi Usa
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065179
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065179
Suppliers and Packaging for NDA: 065179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065179 ANDA Cardinal Health 55154-9382 55154-9382-5 5 VIAL in 1 BAG (55154-9382-5) > 5 mL in 1 VIAL
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065179 ANDA Cardinal Health 55154-9385 55154-9385-5 5 VIAL in 1 BAG (55154-9385-5) > 4.8 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 13, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
Chubb
AstraZeneca
Citi
Merck
Cantor Fitzgerald
Queensland Health
Boehringer Ingelheim

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