Alprazolam

ANDA 74456, held by Watson Labs. Alprazolam.

As of Nov 15, 2026, ANDA 74456 (Alprazolam), held by Watson Labs, was first approved by FDA on Aug 31, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 31, 1995
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 31, 1995	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 17, 1998	Supplement 2Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 3Manufacturing	Approved	None posted
Mar 27, 1997	Supplement 1Labeling	Approved	None posted
Aug 31, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74456
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