Remeron Soltab

Treats major depressive disorder (MDD). NDA 21208, held by Organon USA Organon. Mirtazapine.

As of Nov 14, 2026, NDA 21208 (Remeron Soltab), held by Organon USA Organon, was first approved by FDA on Jan 12, 2001, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 12, 2001
Review: Standard
Supplements approved: 22
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 23 submissions below

Date	Submission	Status	Documents
Jan 12, 2001	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Remeron Soltab15MG · tablet, orally disintegrating;oral	Mirtazapine	RxReference drug
Remeron Soltab30MG · tablet, orally disintegrating;oral	Mirtazapine	RxReference drug
Remeron Soltab45MG · tablet, orally disintegrating;oral	Mirtazapine	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Nov 18, 2021	Supplement 28Labeling · Standard review	Approved	Label Medication Guide
Apr 29, 2020	Supplement 24Labeling · Standard review	Approved	Letter Letter Label
Apr 29, 2020	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 4, 2020	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 5, 2019	Supplement 25Labeling · Standard review	Approved	Label Letter
Jul 8, 2016	Supplement 20Labeling · Standard review	Approved	Label
Dec 30, 2015	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 30, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 21Labeling	Approved	Label Letter
Oct 30, 2012	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 23, 2011	Supplement 12Labeling · Standard review	Approved	Label Letter
May 14, 2010	Supplement 13Labeling	Approved	Label Letter
May 14, 2010	Supplement 14Labeling	Approved	Label Letter
Jul 30, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 9Labeling · Standard review	Approved	Label Letter
Jun 1, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Nov 14, 2002	Supplement 6Labeling · Standard review	Approved	Letter
May 21, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 3, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 20, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 23, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 22, 2001	Supplement 1Labeling · Standard review	Approved	None posted
Jan 12, 2001	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21208
Drugs@FDA: Overview at FDA
Company: Organon USA 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