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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 065398


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NDA 065398 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zhejiang Poly Pharm, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Pharmobedient, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Extrovis, Lupin Ltd, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-nine 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-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065398
Tradename:AZITHROMYCIN
Applicant:Lupin Ltd
Ingredient:azithromycin
Patents:0
Pharmacology for NDA: 065398
Medical Subject Heading (MeSH) Categories for 065398
Anti-Bacterial Agents
Suppliers and Packaging for NDA: 065398
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065398 ANDA Major Pharmaceuticals 0904-7350 0904-7350-06 50 BLISTER PACK in 1 CARTON (0904-7350-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
AZITHROMYCIN azithromycin TABLET;ORAL 065398 ANDA Major Pharmaceuticals 0904-7350 0904-7350-61 100 BLISTER PACK in 1 CARTON (0904-7350-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:May 15, 2015TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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