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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Chinese Patent Office
Boehringer Ingelheim
Fish and Richardson
QuintilesIMS
AstraZeneca
Argus Health
Accenture
Queensland Health
Novartis

Generated: October 21, 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 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-six suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for NDA: 065501

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

Pharmacology for NDA: 065501

Ingredient-typeMacrolides

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:

Federal Trade Commission
Citi
Deloitte
QuintilesIMS
Farmers Insurance
Novartis
Teva
Argus Health
Daiichi Sankyo
Accenture

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