Mirtazapine

ANDA 76901, held by Impax Labs Inc. Mirtazapine.

As of Nov 15, 2026, ANDA 76901 (Mirtazapine), held by Impax Labs Inc, was first approved by FDA on Jun 28, 2005, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 28, 2005
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 28, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Mirtazapine15MG · tablet, orally disintegrating;oral	Mirtazapine	Discontinued
Mirtazapine30MG · tablet, orally disintegrating;oral	Mirtazapine	Discontinued
Mirtazapine45MG · tablet, orally disintegrating;oral	Mirtazapine	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jul 16, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Jul 16, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Jul 16, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Sep 10, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 12Manufacturing	Approved	None posted
Jan 31, 2013	Supplement 7Labeling	Approved	None posted
Jan 31, 2013	Supplement 11Labeling · Standard review	Approved	None posted
Jul 19, 2010	Supplement 6Labeling	Approved	None posted
Nov 13, 2007	Supplement 5Labeling	Approved	None posted
Nov 13, 2007	Supplement 3Labeling	Approved	None posted
Jun 28, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76901
Drugs@FDA: Overview at FDA
Company: Impax 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