Normodyne

NDA 18686, held by Schering. Labetalol Hydrochloride.

As of Nov 13, 2026, NDA 18686 (Normodyne), held by Schering, was first approved by FDA on Aug 1, 1984, with 28 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1984
Review: Priority
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Aug 1, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Normodyne5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Labetalol Hydrochloride	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 6, 2001	Supplement 29Manufacturing · Priority review	Approved	None posted
Jun 5, 2001	Supplement 28Manufacturing · Priority review	Approved	None posted
Nov 16, 2000	Supplement 27Manufacturing · Priority review	Approved	None posted
Apr 25, 2000	Supplement 26Labeling · Priority review	Approved	None posted
Aug 10, 1999	Supplement 25Manufacturing · Priority review	Approved	None posted
Apr 29, 1999	Supplement 24Manufacturing · Priority review	Approved	None posted
Nov 14, 1997	Supplement 23Manufacturing · Priority review	Approved	None posted
Jul 9, 1997	Supplement 22Manufacturing · Priority review	Approved	None posted
Nov 25, 1996	Supplement 21Labeling · Priority review	Approved	None posted
Nov 7, 1996	Supplement 20Manufacturing · Priority review	Approved	None posted
Jan 12, 1995	Supplement 19Labeling · Priority review	Approved	None posted
May 28, 1993	Supplement 18Manufacturing · Priority review	Approved	None posted
Oct 15, 1992	Supplement 16Labeling · Priority review	Approved	None posted
Sep 16, 1991	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 7, 1990	Supplement 15Labeling · Priority review	Approved	None posted
Oct 19, 1989	Supplement 13Labeling · Priority review	Approved	None posted
Oct 19, 1989	Supplement 10Labeling · Priority review	Approved	None posted
Jul 21, 1989	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 22, 1988	Supplement 11Manufacturing · Priority review	Approved	None posted
Apr 14, 1988	Supplement 9Labeling · Priority review	Approved	None posted
Aug 31, 1987	Supplement 6Labeling · Priority review	Approved	None posted
Aug 31, 1987	Supplement 5Labeling · Priority review	Approved	None posted
Jun 12, 1987	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 5, 1987	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 29, 1986	Supplement 4Manufacturing · Priority review	Approved	None posted
Aug 8, 1986	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 4, 1986	Supplement 1Manufacturing · Priority review	Approved	None posted
Jan 14, 1986	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 1, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18686
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