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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 050730

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NDA 050730 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from four suppliers. Additional details are available on the ZITHROMAX profile page.

The generic ingredient in ZITHROMAX is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 050730

Tradename:	ZITHROMAX
Applicant:	Pfizer
Ingredient:	azithromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 050730

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 12, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 050730

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050730-001	Jun 12, 1996	6,268,489	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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