Triazolam

Treats insomnia (generally 7 to 10 days). ANDA 214219, held by Ingenus Pharms LLC. Triazolam.

As of Nov 14, 2026, ANDA 214219 (Triazolam), held by Ingenus Pharms LLC, was first approved by FDA on Oct 20, 2020, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2020
Review: Standard
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Oct 20, 2020	Original application	Approved	None posted

Products

2 strengths and forms


Triazolam0.125MG · tablet;oral	Triazolam	Rx
Triazolam0.25MG · tablet;oral	Triazolam	Rx

All 5 submissions, including labeling and manufacturing supplements


Nov 28, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Jul 26, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Jul 26, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Jul 26, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Oct 20, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 214219
Drugs@FDA: Overview at FDA
Company: Ingenus Pharmaceuticals

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