Aquatensen

NDA 17364, held by Medpointe Pharm Hlc. Methyclothiazide.

As of Nov 14, 2026, NDA 17364 (Aquatensen), held by Medpointe Pharm Hlc, was first approved by FDA on Sep 7, 1977, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 7, 1977
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 7, 1977	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aquatensen5MG · tablet;oral	Methyclothiazide	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 12, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 20, 1992	Supplement 10Labeling	Approved	None posted
Dec 3, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 22, 1988	Supplement 8Labeling	Approved	None posted
Sep 29, 1987	Supplement 4Labeling	Approved	None posted
Jan 24, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 28, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 15, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 16, 1980	Supplement 1Labeling	Approved	None posted
Nov 26, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 7, 1977	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17364
Drugs@FDA: Overview at FDA
Company: Medpointe Pharmaceuticals

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