Alprazolam

ANDA 74215, held by Mylan. Alprazolam.

As of Nov 15, 2026, ANDA 74215 (Alprazolam), held by Mylan, was first approved by FDA on Jan 27, 1994, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1994
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jan 27, 1994	Original application	Approved	None posted

Products

4 strengths and forms


Alprazolam0.25MG · tablet;oral	Alprazolam	Discontinued
Alprazolam0.5MG · tablet;oral	Alprazolam	Discontinued
Alprazolam1MG · tablet;oral	Alprazolam	Discontinued
Alprazolam2MG · tablet;oral	Alprazolam	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jul 3, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Dec 31, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Jun 1, 2012	Supplement 19Manufacturing	Approved	None posted
Sep 27, 2011	Supplement 20Labeling	Approved	None posted
Jun 28, 2008	Supplement 18Labeling	Approved	None posted
Apr 3, 2002	Supplement 6Labeling	Approved	None posted
Oct 18, 2000	Supplement 5Labeling	Approved	None posted
May 6, 1998	Supplement 4Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 2Manufacturing	Approved	None posted
Feb 3, 1998	Supplement 3Manufacturing	Approved	None posted
Nov 7, 1997	Supplement 1Labeling	Approved	None posted
Jan 27, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74215
Drugs@FDA: Overview at FDA
Company: Mylan

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