Last Updated: September 24, 2026

Details for New Drug Application (NDA): 065500

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NDA 065500 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, Lupin, Strides Pharma, Sunshine, Teva, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-six 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-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 065500

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

Medical Subject Heading (MeSH) Categories for 065500

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 26, 2009	TE:	AP	RLD:	No

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