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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 050762

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NDA 050762 describes TROVAN/ZITHROMAX COMPLIANCE PAK, which is a drug marketed by Pfizer and is included in one NDA. Additional details are available on the TROVAN/ZITHROMAX COMPLIANCE PAK profile page.

The generic ingredient in TROVAN/ZITHROMAX COMPLIANCE PAK is azithromycin dihydrate; trovafloxacin mesylate. There are thirty-two drug master file entries for this compound. Additional details are available on the azithromycin dihydrate; trovafloxacin mesylate profile page.

Summary for 050762

Tradename:	TROVAN/ZITHROMAX COMPLIANCE PAK
Applicant:	Pfizer
Ingredient:	azithromycin dihydrate; trovafloxacin mesylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION, TABLET;ORAL			Strength	EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
Approval Date:	Dec 18, 1998	TE:		RLD:	No

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