Triazolam

ANDA 74445, held by Watson Labs. Triazolam.

As of Nov 14, 2026, ANDA 74445 (Triazolam), held by Watson Labs, was first approved by FDA on Oct 20, 1995, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1995
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 20, 1995	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Apr 19, 1999	Supplement 5Manufacturing	Approved	None posted
Mar 12, 1998	Supplement 4Manufacturing	Approved	None posted
Mar 12, 1998	Supplement 3Manufacturing	Approved	None posted
Jan 24, 1997	Supplement 1Manufacturing	Approved	None posted
Nov 29, 1996	Supplement 2Labeling	Approved	None posted
Oct 20, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74445
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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