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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Mallinckrodt
McKesson
Julphar
Farmers Insurance
Fuji
AstraZeneca
Healthtrust
Deloitte

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065265

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NDA 065265 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: 065265

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

Pharmacology for NDA: 065265

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 065265

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
INJECTABLE;INJECTION 065265 ANDA Cardinal Health 55154-5759 55154-5759-5 5 VIAL in 1 BAG (55154-5759-5) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 18, 2007TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Colorcon
UBS
Queensland Health
Argus Health
Fuji
Moodys
US Army
Teva

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