Mirtazapine

Treats major depressive disorder (MDD). ANDA 216751, held by Prasco. Mirtazapine.

As of Nov 15, 2026, ANDA 216751 (Mirtazapine), held by Prasco, was first approved by FDA on Jan 18, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 18, 2023
Review: Standard
Supplements approved: 1
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 2 submissions below

Date	Submission	Status	Documents
Jan 18, 2023	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 2 submissions, including labeling and manufacturing supplements


Jun 28, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jan 18, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 216751
Drugs@FDA: Overview at FDA
Company: Prasco

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