Alprazolam

ANDA 78442, held by Ph Health. Alprazolam.

As of Nov 15, 2026, ANDA 78442 (Alprazolam), held by Ph Health, was first approved by FDA on Oct 15, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 15, 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
Oct 15, 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 29, 2011	Supplement 2Labeling	Approved	None posted
Oct 15, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78442
Drugs@FDA: Overview at FDA
Company: PH Health

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