Zaleplon

ANDA 77238, held by Natco Pharma. Zaleplon.

As of Nov 14, 2026, ANDA 77238 (Zaleplon), held by Natco Pharma, 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


Jun 13, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Jul 6, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jun 6, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 77238
Drugs@FDA: Overview at FDA
Company: Natco 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