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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
Fuji
Federal Trade Commission
Queensland Health
Medtronic
Harvard Business School
Cipla
McKinsey

Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065398

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NDA 065398 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 065398
Tradename:AZITHROMYCIN
Applicant:Lupin Ltd
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065398
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065398
Suppliers and Packaging for NDA: 065398
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065398 ANDA PD-Rx Pharmaceuticals, Inc. 43063-728 N 43063-728-02
AZITHROMYCIN azithromycin TABLET;ORAL 065398 ANDA PD-Rx Pharmaceuticals, Inc. 43063-728 N 43063-728-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:May 15, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Argus Health
Cerilliant
AstraZeneca
Boehringer Ingelheim
Harvard Business School
Julphar
Colorcon
Deloitte

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