Zaleplon

ANDA 78706, held by Upsher Smith Labs. Zaleplon.

As of Nov 14, 2026, ANDA 78706 (Zaleplon), held by Upsher Smith Labs, was first approved by FDA on Jun 6, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 6, 2008
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 6, 2008	Original application	Approved	Letter

Products

2 strengths and forms


Zaleplon5MG · capsule;oral	Zaleplon	Discontinued
Zaleplon10MG · capsule;oral	Zaleplon	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 26, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Sep 3, 2008	Supplement 2Labeling	Approved	None posted
Jun 6, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 78706
Drugs@FDA: Overview at FDA
Company: Upsher-Smith 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