Mirtazapine

Treats major depressive disorder (MDD). ANDA 76541, held by Sun Pharm Inds Inc. Mirtazapine.

As of Nov 15, 2026, ANDA 76541 (Mirtazapine), held by Sun Pharm Inds Inc, was first approved by FDA on Apr 22, 2004, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2004
Supplements approved: 15
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 16 submissions below

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

Products

4 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


Sep 15, 2022	Supplement 27Labeling · Standard review	Approved	None posted
Sep 25, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Sep 25, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Nov 20, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 20Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Jun 17, 2015	Supplement 18Manufacturing	Approved	None posted
Jun 3, 2008	Supplement 11Labeling	Approved	None posted
Nov 7, 2007	Supplement 10Labeling	Approved	None posted
Oct 29, 2007	Supplement 9Labeling	Approved	None posted
Mar 26, 2007	Supplement 8Labeling	Approved	None posted
Jul 12, 2005	Supplement 4Labeling	Approved	None posted
Jul 12, 2005	Supplement 5Labeling	Approved	None posted
Mar 10, 2005	Supplement 2Labeling	Approved	None posted
Mar 10, 2005	Supplement 3Labeling	Approved	None posted
Apr 22, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76541
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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