Mirtazapine

Treats major depressive disorder (MDD). ANDA 77376, held by Aurobindo Pharma. Mirtazapine.

As of Nov 15, 2026, ANDA 77376 (Mirtazapine), held by Aurobindo Pharma, was first approved by FDA on Feb 28, 2006, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2006
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Feb 28, 2006	Original applicationLabeling	Approved	None posted
Dec 8, 2005	Original application	Approved	None posted

Products

3 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


May 8, 2025	Supplement 28Labeling · Standard review	Approved	None posted
Aug 16, 2021	Supplement 23Labeling · Standard review	Approved	None posted
Aug 16, 2021	Supplement 25Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 22Labeling · Standard review	Approved	None posted
Jan 16, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Apr 19, 2013	Supplement 11Labeling	Approved	None posted
Apr 19, 2013	Supplement 12Labeling · Standard review	Approved	None posted
Jun 28, 2011	Supplement 8Labeling	Approved	None posted
Oct 30, 2007	Supplement 4Labeling	Approved	None posted
Oct 30, 2007	Supplement 5Labeling	Approved	None posted
Feb 28, 2006	Supplement 1Manufacturing	Approved	None posted
Feb 28, 2006	Original applicationLabeling	Approved	None posted
Feb 28, 2006	Supplement 2Labeling	Approved	None posted
Dec 8, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77376
Drugs@FDA: Overview at FDA
Company: Aurobindo 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