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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Moodys
Fish and Richardson
Teva
Express Scripts
McKinsey
UBS
QuintilesIMS
Cerilliant

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065405

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NDA 065405 describes AZITHROMYCIN, which is a drug marketed by Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-six 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 065405
Tradename:AZITHROMYCIN
Applicant:Wockhardt
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065405
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065405
Suppliers and Packaging for NDA: 065405
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065405 ANDA Rebel Distributors Corp. 21695-013 E 21695-013-03
AZITHROMYCIN azithromycin TABLET;ORAL 065405 ANDA Aidarex Pharmaceuticals LLC 33261-879 N 33261-879-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Feb 11, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Deloitte
UBS
Boehringer Ingelheim
Merck
Baxter
Healthtrust
Moodys

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