Alprazolam

ANDA 90082, held by Sun Pharm. Alprazolam.

As of Nov 15, 2026, ANDA 90082 (Alprazolam), held by Sun Pharm, was first approved by FDA on Jun 17, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 17, 2010
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
Jun 17, 2010	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 2 submissions, including labeling and manufacturing supplements


Mar 14, 2013	Supplement 1Labeling	Approved	None posted
Jun 17, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90082
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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