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Serving leading biopharmaceutical companies globally:

Baxter
Citi
Daiichi Sankyo
UBS
Johnson and Johnson
Cipla
Federal Trade Commission
Accenture
Mallinckrodt
Novartis

Generated: November 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065400

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NDA 065400 describes AZITHROMYCIN, which is a drug marketed by Hospira, Lupin Ltd, Gland Pharma Ltd, Wockhardt, Sagent Strides, Apotex Corp, Teva Parenteral, Sandoz, Pliva, Teva Pharms, Sun Pharm Inds Ltd, Mylan Labs Ltd, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in thirty-five NDAs. It is available from fifty 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 065400

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065400

Ingredient-typeMacrolides

Medical Subject Heading (MeSH) Categories for 065400

Suppliers and Packaging for NDA: 065400

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
TABLET;ORAL 065400 ANDA LUPIN LIMITED 57297-162 57297-162-06 30 TABLET in 1 CONTAINER (57297-162-06)
AZITHROMYCIN
azithromycin
TABLET;ORAL 065400 ANDA American Health Packaging 60687-314 60687-314-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-314-25) > 1 TABLET in 1 BLISTER PACK (60687-314-95)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE
Approval Date:May 15, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
McKesson
Federal Trade Commission
Novartis
Queensland Health
Cipla
Colorcon
UBS
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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