BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
US Department of Justice
Medtronic
Daiichi Sankyo
Chinese Patent Office
AstraZeneca
Queensland Health
Baxter
Cantor Fitzgerald
Johnson and Johnson

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065399

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NDA 065399 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 065399
Tradename:AZITHROMYCIN
Applicant:Lupin Ltd
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065399
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065399
Suppliers and Packaging for NDA: 065399
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065399 ANDA PD-Rx Pharmaceuticals, Inc. 43063-713 43063-713-02 2 TABLET in 1 BOTTLE, PLASTIC (43063-713-02)
AZITHROMYCIN azithromycin TABLET;ORAL 065399 ANDA PD-Rx Pharmaceuticals, Inc. 43063-713 43063-713-07 7 TABLET in 1 BOTTLE, PLASTIC (43063-713-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:May 15, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
Accenture
UBS
Boehringer Ingelheim
Fuji
Cantor Fitzgerald
Dow
Julphar
Medtronic

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