Remeron

Treats major depressive disorder (MDD). NDA 20415, held by Organon. Mirtazapine.

As of Nov 14, 2026, NDA 20415 (Remeron), held by Organon, was first approved by FDA on Jun 14, 1996, with 30 approved supplements and 0 published complete response letters.

First approved: Jun 14, 1996
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

REMERON/REMERONSolTab 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 31 submissions below


Apr 9, 2002	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 14, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms


Remeron15MG · tablet;oral	Mirtazapine	RxReference drug
Remeron30MG · tablet;oral	Mirtazapine	RxReference drug
Remeron45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Mirtazapine	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Jul 23, 2025	Supplement 39Manufacturing · Standard review	Approved	Letter Label
Nov 18, 2021	Supplement 38Labeling · Standard review	Approved	Label Medication Guide
Apr 29, 2020	Supplement 36Labeling · Standard review	Approved	Letter Label
Apr 29, 2020	Supplement 34Labeling · Standard review	Approved	Letter Label
Mar 4, 2020	Supplement 29Labeling · Standard review	Approved	Label Letter
Sep 5, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
Jul 8, 2016	Supplement 30Labeling · Standard review	Approved	Label
Dec 30, 2015	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 30, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 31Labeling	Approved	Label Letter
Dec 11, 2012	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 30, 2012	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 27, 2011	Supplement 22Labeling · Standard review	Approved	Letter Label
May 14, 2010	Supplement 24Labeling	Approved	Label Letter
May 14, 2010	Supplement 23Labeling	Approved	Label Letter
Jul 30, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 18Labeling · Standard review	Approved	Letter Label
Jun 1, 2004	Supplement 16Labeling · Standard review	Approved	Letter
Sep 30, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Apr 9, 2002	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter
Nov 20, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 26, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 30, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Jul 19, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 28, 2000	Supplement 7Labeling · Standard review	Approved	None posted
May 11, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 9, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 17, 1997	Supplement 3Manufacturing · Standard review	Approved	Review
Nov 7, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 4, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 14, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20415
Drugs@FDA: Overview at FDA
Company: Organon

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