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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 065150

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NDA 065150 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Hainan Poly, Pliva, Sandoz, Taro, Teva Pharms, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Norvium Bioscience, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Pharmobedient, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from sixty-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. Sixty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 065150

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

Medical Subject Heading (MeSH) Categories for 065150

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE
Approval Date:	Nov 14, 2005	TE:		RLD:	No

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