Normodyne

NDA 18687, held by Schering. Labetalol Hydrochloride.

As of Nov 14, 2026, NDA 18687 (Normodyne), held by Schering, was first approved by FDA on Aug 1, 1984, with 21 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1984
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Aug 1, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Normodyne100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug
Normodyne200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug
Normodyne300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug
Normodyne400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Dec 22, 2000	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 27, 2000	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 25, 2000	Supplement 21Labeling · Standard review	Approved	None posted
Jan 27, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
May 28, 1993	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 27, 1993	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 15, 1992	Supplement 16Labeling · Standard review	Approved	None posted
Sep 16, 1991	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 7, 1990	Supplement 15Labeling · Standard review	Approved	None posted
Jun 16, 1989	Supplement 14Labeling · Standard review	Approved	None posted
Jun 16, 1989	Supplement 12Labeling · Standard review	Approved	None posted
Feb 23, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 22, 1988	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 14, 1988	Supplement 10Labeling · Standard review	Approved	None posted
Aug 31, 1987	Supplement 8Labeling · Standard review	Approved	None posted
Aug 31, 1987	Supplement 5Labeling · Standard review	Approved	None posted
Aug 31, 1987	Supplement 2Labeling · Standard review	Approved	None posted
Feb 5, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 14, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 28, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 1, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18687
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