Zmax

NDA 50797, held by Pf Prism Cv. Azithromycin.

As of Nov 13, 2026, NDA 50797 (Zmax), held by Pf Prism Cv, was first approved by FDA on Jun 10, 2005, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 10, 2005
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Oct 7, 2008	Supplement 8Efficacy (new indication or use)	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jun 10, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZmaxEQ 2GM BASE/BOT · for suspension, extended release;oral	Azithromycin	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 22, 2021	Supplement 26Labeling · Standard review	Approved	Letter Label
Apr 24, 2019	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 30, 2017	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 9, 2017	Supplement 21Labeling · Standard review	Approved	Letter Label
Jun 27, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
May 24, 2016	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 2, 2015	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 11, 2013	Supplement 13Labeling · Standard review	Approved	Label Letter
Feb 19, 2013	Supplement 17Labeling · Standard review	Approved	Label Letter
Mar 1, 2012	Supplement 16Labeling · Standard review	Approved	Label Letter
Jun 7, 2011	Supplement 10Labeling	Approved	Label Letter
Jun 7, 2011	Supplement 12Labeling	Approved	Label Letter
Jun 7, 2011	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 7, 2008	Supplement 8Efficacy (new indication or use)	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Oct 25, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 10, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 50797
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters