Normozide

NDA 19046, held by Schering. Hydrochlorothiazide; Labetalol Hydrochloride.

As of Nov 13, 2026, NDA 19046 (Normozide), held by Schering, was first approved by FDA on Apr 6, 1987, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 6, 1987
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 6, 1987	Original applicationNew combination · Standard review	Approved	None posted

Products

4 strengths and forms


Normozide25MG;100MG · tablet;oral	Hydrochlorothiazide; Labetalol Hydrochloride	Discontinued
Normozide25MG;200MG · tablet;oral	Hydrochlorothiazide; Labetalol Hydrochloride	Discontinued
Normozide25MG;300MG · tablet;oral	Hydrochlorothiazide; Labetalol Hydrochloride	Discontinued
Normozide25MG;400MG · tablet;oral	Hydrochlorothiazide; Labetalol Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 7, 1990	Supplement 7Labeling	Approved	None posted
Jun 16, 1989	Supplement 4Labeling	Approved	None posted
Jun 16, 1989	Supplement 6Labeling	Approved	None posted
Apr 14, 1988	Supplement 2Labeling	Approved	None posted
Apr 6, 1987	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 19046
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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