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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 050784

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NDA 050784 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from eight 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-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 050784

Tradename:	ZITHROMAX
Applicant:	Pfizer
Ingredient:	azithromycin
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 050784

Medical Subject Heading (MeSH) Categories for 050784

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 050784

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZITHROMAX	azithromycin	TABLET;ORAL	050784	NDA	Pfizer Laboratories Div Pfizer Inc	0069-3070	0069-3070-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30)
ZITHROMAX	azithromycin	TABLET;ORAL	050784	NDA	Pfizer Laboratories Div Pfizer Inc	0069-3070	0069-3070-75	3 BLISTER PACK in 1 CARTON (0069-3070-75) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	May 24, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050784

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050784-001	May 24, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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