Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065193

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NDA 065193 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, Hainan Poly, Hikma, Hospira, Pharmobedient, Rising, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Carlsbad, Cspc Ouyi, Extrovis, Fosun Pharma, Lupin, Strides Pharma, Sunshine, Teva, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-five suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There is one drug master file entry for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 065193

Tradename:	AZITHROMYCIN
Applicant:	Teva
Ingredient:	azithromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065193

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Nov 14, 2005	TE:	AB	RLD:	No

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