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Serving leading biopharmaceutical companies globally:

McKinsey
Healthtrust
Boehringer Ingelheim
Queensland Health
Cerilliant
Colorcon
Harvard Business School
Novartis
Fuji
Argus Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065501

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NDA 065501 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-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 065501

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

Pharmacology for NDA: 065501

Ingredient-typeMacrolides

Medical Subject Heading (MeSH) Categories for 065501

Suppliers and Packaging for NDA: 065501

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065501 ANDA APOTEX CORP. 60505-6076 60505-6076-4 10 VIAL in 1 CARTON (60505-6076-4) > 10 mL in 1 VIAL
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065501 ANDA Gland Pharma Limited 68083-199 68083-199-10 10 VIAL in 1 CARTON (68083-199-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Nov 9, 2009TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Citi
Cipla
Federal Trade Commission
Julphar
Argus Health
Mallinckrodt
Boehringer Ingelheim
Healthtrust
Teva

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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