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Generated: October 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065179

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NDA 065179 describes AZITHROMYCIN, which is a drug marketed by Amneal Pharms Llc, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Zydus Worldwide, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in forty-three NDAs. It is available from fifty-four 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. Sixty suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065179
Tradename:AZITHROMYCIN
Applicant:Fresenius Kabi Usa
Ingredient:azithromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065179
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065179
Suppliers and Packaging for NDA: 065179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065179 ANDA Cardinal Health 55154-9382 55154-9382-5 5 VIAL in 1 BAG (55154-9382-5) > 5 mL in 1 VIAL
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065179 ANDA Fresenius Kabi USA, LLC 63323-398 63323-398-10 10 VIAL in 1 TRAY (63323-398-10) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 13, 2005TE:APRLD:No

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