Mykrox

NDA 19532, held by Chartwell Molecular. Metolazone.

As of Nov 13, 2026, NDA 19532 (Mykrox), held by Chartwell Molecular, was first approved by FDA on Oct 30, 1987, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1987
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 30, 1987	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mykrox0.5MG · tablet;oral	Metolazone	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 19, 2003	Supplement 16Labeling · Standard review	Approved	Letter
Oct 29, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Apr 17, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 1, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 18, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 10, 2001	Supplement 12Labeling · Standard review	Approved	Label
Sep 8, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
May 16, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 31, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
May 23, 1995	Supplement 6Labeling · Standard review	Approved	None posted
Jan 13, 1994	Supplement 5Labeling · Standard review	Approved	None posted
Jan 13, 1993	Supplement 4Labeling · Standard review	Approved	None posted
Sep 13, 1991	Supplement 3Labeling	Approved	None posted
Sep 20, 1988	Supplement 2Labeling	Approved	None posted
Oct 30, 1987	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 19532
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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