Triazolam

ANDA 74031, held by Pharmobedient. Triazolam.

As of Nov 14, 2026, ANDA 74031 (Triazolam), held by Pharmobedient, was first approved by FDA on Mar 25, 1994, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1994
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 25, 1994	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Sep 18, 2008	Supplement 5Labeling	Approved	None posted
Mar 18, 2004	Supplement 4Labeling	Approved	None posted
Mar 27, 1997	Supplement 2Labeling	Approved	None posted
Jul 6, 1994	Supplement 1Manufacturing	Approved	None posted
Mar 25, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74031
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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