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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 050710

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NDA 050710 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 050710

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

Pharmacology for NDA: 050710

Medical Subject Heading (MeSH) Categories for 050710

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 050710

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710	NDA	Pfizer Laboratories Div Pfizer Inc	0069-3110	0069-3110-19	1 BOTTLE in 1 CARTON (0069-3110-19) / 15 mL in 1 BOTTLE
ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710	NDA	Pfizer Laboratories Div Pfizer Inc	0069-3120	0069-3120-19	1 BOTTLE in 1 CARTON (0069-3120-19) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 100MG BASE/5ML
Approval Date:	Oct 19, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 200MG BASE/5ML
Approval Date:	Oct 19, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050710

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-001	Oct 19, 1995	⤷ Get Started Free	⤷ Get Started Free
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-002	Oct 19, 1995	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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