Mirtazapine

Treats major depressive disorder (MDD). ANDA 76921, held by Aurobindo. Mirtazapine.

As of Nov 15, 2026, ANDA 76921 (Mirtazapine), held by Aurobindo, was first approved by FDA on Oct 22, 2004, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2004
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mirtazapine 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 19 submissions below

Date	Submission	Status	Documents
Oct 22, 2004	Original application	Approved	None posted

Products

4 strengths and forms


Mirtazapine7.5MG · tablet;oral	Mirtazapine	Rx
Mirtazapine15MG · tablet;oral	Mirtazapine	Rx
Mirtazapine30MG · tablet;oral	Mirtazapine	Rx
Mirtazapine45MG · tablet;oral	Mirtazapine	Rx

All 19 submissions, including labeling and manufacturing supplements


Sep 15, 2022	Supplement 41Labeling · Standard review	Approved	None posted
Jul 6, 2021	Supplement 36Labeling · Standard review	Approved	None posted
Jul 6, 2021	Supplement 38Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 29Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 30Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 35Labeling · Standard review	Approved	None posted
Jan 16, 2015	Supplement 26Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 23Labeling	Approved	None posted
Jan 31, 2013	Supplement 24Labeling · Standard review	Approved	None posted
Jun 6, 2011	Supplement 15Labeling	Approved	None posted
Dec 30, 2010	Supplement 20Labeling	Approved	None posted
Nov 26, 2007	Supplement 10Labeling	Approved	None posted
Nov 26, 2007	Supplement 11Labeling	Approved	None posted
Aug 21, 2007	Supplement 8Labeling	Approved	None posted
Apr 9, 2007	Supplement 4Labeling	Approved	None posted
Jan 16, 2007	Supplement 5Labeling	Approved	None posted
Jul 21, 2006	Supplement 2Labeling	Approved	None posted
Dec 28, 2005	Supplement 1Labeling	Approved	None posted
Oct 22, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76921
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