Metahydrin

NDA 12594, held by Sanofi Aventis US. Trichlormethiazide.

As of Nov 13, 2026, NDA 12594 (Metahydrin), held by Sanofi Aventis US, was not approved, with 6 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 6
Complete response letters: 0

Products

2 strengths and forms


Metahydrin2MG · tablet;oral	Trichlormethiazide	Discontinued
Metahydrin4MG · tablet;oral	Trichlormethiazide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 28, 1994	Supplement 18Labeling · Standard review	Approved	None posted
Jun 23, 1989	Supplement 17Labeling · Standard review	Approved	None posted
Jun 16, 1988	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 16, 1988	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 16, 1988	Supplement 13Labeling · Standard review	Approved	None posted
Jun 16, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted

Identifiers

Application: NDA 12594
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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