Mirtazapine

Treats major depressive disorder (MDD). ANDA 205798, held by Square Pharms PLC. Mirtazapine.

As of Nov 15, 2026, ANDA 205798 (Mirtazapine), held by Square Pharms PLC, was first approved by FDA on Jun 1, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2017
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Jun 1, 2017	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 3 submissions, including labeling and manufacturing supplements


Dec 6, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Oct 16, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jun 1, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205798
Drugs@FDA: Overview at FDA
Company: Square Pharmaceuticals

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