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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 050693

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NDA 050693 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from three 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 050693

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

Medical Subject Heading (MeSH) Categories for 050693

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 050693

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-3051	59762-3051-2	3 PACKET in 1 BOX (59762-3051-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 1GM BASE/PACKET
Approval Date:	Sep 28, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 050693

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693-001	Sep 28, 1994	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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