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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Queensland Health
McKinsey
UBS
Medtronic
Fish and Richardson
Fuji
QuintilesIMS
Argus Health

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065488

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NDA 065488 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-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 065488
Tradename:AZITHROMYCIN
Applicant:Lupin Ltd
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065488
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065488
Suppliers and Packaging for NDA: 065488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065488 ANDA Lupin Pharmaceuticals,Inc. 43386-470 N 43386-470-60
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065488 ANDA Lupin Pharmaceuticals,Inc. 43386-471 N 43386-471-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:May 15, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 26, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:May 15, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 26, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Farmers Insurance
Teva
QuintilesIMS
US Army
Healthtrust
Moodys
Medtronic
Cerilliant

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