Dalmane

NDA 16721, held by Valeant Pharm Intl. Flurazepam Hydrochloride.

As of Nov 14, 2026, NDA 16721 (Dalmane), held by Valeant Pharm Intl, was first approved by FDA on Apr 7, 1970, with 44 approved supplements and 0 published complete response letters.

First approved: Apr 7, 1970
Review: Priority
Supplements approved: 44
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 45 submissions below

Date	Submission	Status	Documents
Apr 7, 1970	Original applicationNew molecular entity · Priority review	Approved	Medication Guide

Products

2 strengths and forms


Dalmane15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Flurazepam Hydrochloride	Discontinued
Dalmane30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Flurazepam Hydrochloride	DiscontinuedReference drug

All 45 submissions, including labeling and manufacturing supplements


Mar 27, 2009	Supplement 77Labeling · Priority review	Approved	Label Letter
Oct 30, 2007	Supplement 76Labeling · Priority review	Approved	Letter Label
Aug 12, 2002	Supplement 75Manufacturing · Priority review	Approved	None posted
Jun 14, 2001	Supplement 74Labeling · Priority review	Approved	Letter
May 25, 1993	Supplement 72Manufacturing · Priority review	Approved	None posted
Dec 31, 1992	Supplement 71Manufacturing · Priority review	Approved	None posted
Apr 25, 1990	Supplement 70Manufacturing · Priority review	Approved	None posted
Jan 16, 1990	Supplement 68Manufacturing · Priority review	Approved	None posted
Nov 7, 1989	Supplement 67Manufacturing · Priority review	Approved	None posted
Nov 9, 1987	Supplement 66Labeling · Priority review	Approved	None posted
Dec 11, 1984	Supplement 64Manufacturing · Priority review	Approved	None posted
Jun 15, 1982	Supplement 63Manufacturing · Priority review	Approved	None posted
Jan 28, 1982	Supplement 62Manufacturing · Priority review	Approved	None posted
Dec 22, 1981	Supplement 61Manufacturing · Priority review	Approved	None posted
Dec 22, 1981	Supplement 60Manufacturing · Priority review	Approved	None posted
Nov 5, 1981	Supplement 59Manufacturing · Priority review	Approved	None posted
Aug 4, 1981	Supplement 57Manufacturing · Priority review	Approved	None posted
Jul 17, 1981	Supplement 56Manufacturing · Priority review	Approved	None posted
May 6, 1981	Supplement 54Labeling · Priority review	Approved	None posted
Mar 26, 1981	Supplement 55Manufacturing · Priority review	Approved	None posted
Aug 20, 1980	Supplement 52Manufacturing · Priority review	Approved	None posted
Aug 20, 1980	Supplement 51Manufacturing · Priority review	Approved	None posted
Jul 11, 1980	Supplement 50Manufacturing · Priority review	Approved	None posted
Jun 17, 1980	Supplement 48Manufacturing · Priority review	Approved	None posted
Jun 17, 1980	Supplement 49Manufacturing · Priority review	Approved	None posted
Feb 4, 1980	Supplement 47Manufacturing · Priority review	Approved	None posted
Nov 9, 1979	Supplement 46Manufacturing · Priority review	Approved	None posted
Sep 17, 1979	Supplement 45Manufacturing · Priority review	Approved	None posted
May 1, 1979	Supplement 44Manufacturing · Priority review	Approved	None posted
Mar 26, 1979	Supplement 43Manufacturing · Priority review	Approved	None posted
Jul 28, 1978	Supplement 42Manufacturing · Priority review	Approved	None posted
Jul 20, 1978	Supplement 40Labeling · Priority review	Approved	None posted
Jul 12, 1978	Supplement 41Manufacturing · Priority review	Approved	None posted
Jul 10, 1978	Supplement 30Labeling · Priority review	Approved	None posted
Jul 10, 1978	Supplement 39Labeling · Priority review	Approved	None posted
May 2, 1978	Supplement 38Manufacturing · Priority review	Approved	None posted
Aug 2, 1977	Supplement 34Labeling · Priority review	Approved	None posted
Jul 12, 1977	Supplement 37Manufacturing · Priority review	Approved	None posted
Jun 29, 1977	Supplement 36Manufacturing · Priority review	Approved	None posted
Dec 10, 1976	Supplement 32Labeling · Priority review	Approved	None posted
Jul 1, 1975	Supplement 27Manufacturing · Priority review	Approved	None posted
Jan 16, 1975	Supplement 25Manufacturing · Priority review	Approved	None posted
Sep 17, 1974	Supplement 24Manufacturing · Priority review	Approved	None posted
Apr 22, 1974	Supplement 23Labeling · Priority review	Approved	None posted
Apr 7, 1970	Original applicationNew molecular entity · Priority review	Approved	Medication Guide

Identifiers

Application: NDA 16721
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals International

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