Hydromox

NDA 13264, held by Lederle. Quinethazone.

As of Nov 13, 2026, NDA 13264 (Hydromox), held by Lederle, was first approved by FDA on Apr 10, 1963, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 10, 1963
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 10, 1963	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydromox50MG · tablet;oral	Quinethazone	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 15, 1987	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 15, 1983	Supplement 25Manufacturing · Standard review	Approved	None posted
May 21, 1982	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 21, 1980	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 28, 1978	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 28, 1978	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 7, 1978	Supplement 20Labeling · Standard review	Approved	None posted
Apr 10, 1963	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 13264
Drugs@FDA: Overview at FDA
Company: Lederle Laboratories

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