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Serving leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
AstraZeneca
Citi
Cantor Fitzgerald
UBS
Chubb
Healthtrust
Merck
Julphar

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065209

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NDA 065209 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-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 NDA: 065209

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

Pharmacology for NDA: 065209

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 065209

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
TABLET;ORAL 065209 ANDA Sandoz Inc 0781-1497 0781-1497-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-1497-31)
AZITHROMYCIN
azithromycin
TABLET;ORAL 065209 ANDA Sandoz Inc 0781-5793 0781-5793-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-5793-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE
Approval Date:Nov 14, 2005TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
McKesson
Harvard Business School
US Army
Chubb
Fish and Richardson
AstraZeneca
Fuji
Cerilliant
Merck

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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