Halcion

Treats insomnia (generally 7 to 10 days). NDA 17892, held by Pfizer. Triazolam.

As of Nov 14, 2026, NDA 17892 (Halcion), held by Pfizer, was first approved by FDA on Nov 15, 1982, with 39 approved supplements and 0 published complete response letters.

First approved: Nov 15, 1982
Review: Priority
Supplements approved: 39
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 40 submissions below

Date	Submission	Status	Documents
Nov 15, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Halcion0.25MG · tablet;oral	Triazolam	RxReference drug
Halcion0.5MG · tablet;oral	Triazolam	Discontinued
Halcion0.125MG · tablet;oral	Triazolam	RxReference drug

All 40 submissions, including labeling and manufacturing supplements


Jan 13, 2023	Supplement 57Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 27, 2021	Supplement 56Labeling · Standard review	Approved	Label Letter
Feb 5, 2021	Supplement 55Labeling	Approved	Label Letter
Oct 9, 2019	Supplement 50Labeling · Standard review	Approved	Letter Label
Feb 6, 2019	Supplement 54Labeling	Approved	Letter Label
Dec 16, 2016	Supplement 49Labeling	Approved	Letter Label
Dec 15, 2015	Supplement 48Manufacturing · Priority review	Approved	None posted
Sep 18, 2014	Supplement 47Labeling · Standard review	Approved	Letter Label
Jan 21, 2014	Supplement 45Manufacturing · Priority review	Approved	None posted
Jan 25, 2013	Supplement 44Manufacturing · Priority review	Approved	None posted
Feb 12, 2008	Supplement 38Labeling · Standard review	Approved	Letter Label
Jun 25, 2003	Supplement 34Labeling · Standard review	Approved	Review Letter
Nov 4, 1999	Supplement 35Manufacturing · Priority review	Approved	None posted
Apr 4, 1996	Supplement 33Labeling · Standard review	Approved	None posted
Nov 4, 1994	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 13, 1994	Supplement 31Manufacturing · Priority review	Approved	None posted
Sep 14, 1993	Supplement 30Labeling · Standard review	Approved	None posted
May 25, 1993	Supplement 26Manufacturing · Priority review	Approved	None posted
May 21, 1993	Supplement 21Manufacturing · Priority review	Approved	None posted
Feb 21, 1992	Supplement 24Manufacturing · Priority review	Approved	None posted
Nov 13, 1991	Supplement 23Labeling	Approved	None posted
Jan 17, 1991	Supplement 22Labeling	Approved	None posted
Aug 16, 1990	Supplement 19Labeling	Approved	None posted
Aug 16, 1990	Supplement 18Labeling	Approved	None posted
Aug 16, 1990	Supplement 17Labeling	Approved	None posted
Mar 20, 1989	Supplement 16Labeling	Approved	None posted
Aug 24, 1988	Supplement 9Manufacturing · Priority review	Approved	None posted
Jul 26, 1988	Supplement 13Manufacturing · Priority review	Approved	None posted
May 6, 1988	Supplement 15Labeling	Approved	None posted
May 5, 1988	Supplement 14Labeling	Approved	None posted
Mar 25, 1988	Supplement 12Manufacturing · Priority review	Approved	None posted
Oct 23, 1987	Supplement 11Labeling	Approved	None posted
Oct 23, 1987	Supplement 10Labeling	Approved	None posted
Oct 23, 1987	Supplement 8Labeling	Approved	None posted
Oct 23, 1987	Supplement 7Labeling	Approved	None posted
Oct 23, 1987	Supplement 2Labeling	Approved	None posted
Dec 6, 1985	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 26, 1985	Supplement 4Labeling	Approved	None posted
Apr 26, 1985	Supplement 1Manufacturing · Priority review	Approved	None posted
Nov 15, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17892
Drugs@FDA: Overview at FDA
Company: Pfizer

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