Alprazolam

ANDA 77996, held by Impax Labs Inc. Alprazolam.

As of Nov 15, 2026, ANDA 77996 (Alprazolam), held by Impax Labs Inc, was first approved by FDA on Jan 31, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 31, 2007
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 31, 2007	Original application	Approved	None posted

Products

4 strengths and forms


Alprazolam0.5MG · tablet, extended release;oral	Alprazolam	Discontinued
Alprazolam1MG · tablet, extended release;oral	Alprazolam	Discontinued
Alprazolam2MG · tablet, extended release;oral	Alprazolam	Discontinued
Alprazolam3MG · tablet, extended release;oral	Alprazolam	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 12, 2014	Supplement 4Manufacturing	Approved	None posted
Jan 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77996
Drugs@FDA: Overview at FDA
Company: Impax 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