Alprazolam

ANDA 77391, held by Pharmobedient. Alprazolam.

As of Nov 15, 2026, ANDA 77391 (Alprazolam), held by Pharmobedient, was first approved by FDA on Jan 26, 2006, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2006
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
Jan 26, 2006	Original application	Approved	Letter

Products

4 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 13, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Mar 13, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Jan 8, 2013	Supplement 7Labeling	Approved	None posted
Jan 26, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77391
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