Mirtazapine

ANDA 76119, held by Teva. Mirtazapine.

As of Nov 15, 2026, ANDA 76119 (Mirtazapine), held by Teva, was first approved by FDA on Jan 24, 2003, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 24, 2003
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 24, 2003	Original application	Approved	Review Letter

Products

3 strengths and forms


Mirtazapine15MG · tablet;oral	Mirtazapine	Rx
Mirtazapine30MG · tablet;oral	Mirtazapine	Rx
Mirtazapine45MG · tablet;oral	Mirtazapine	Rx

All 14 submissions, including labeling and manufacturing supplements


Feb 24, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Feb 24, 2020	Supplement 27Labeling · Standard review	Approved	None posted
Feb 24, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Oct 24, 2014	Supplement 24Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 22Labeling	Approved	None posted
Jan 31, 2013	Supplement 23Labeling · Standard review	Approved	None posted
Jul 19, 2010	Supplement 20Labeling	Approved	None posted
Nov 6, 2007	Supplement 13Labeling	Approved	None posted
Nov 6, 2007	Supplement 14Labeling	Approved	None posted
Jul 21, 2006	Supplement 12Labeling	Approved	None posted
Jul 12, 2005	Supplement 6Labeling	Approved	None posted
Dec 29, 2004	Supplement 4Labeling	Approved	None posted
Jun 19, 2003	Supplement 2Labeling	Approved	None posted
Jan 24, 2003	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76119
Drugs@FDA: Overview at FDA
Company: Teva 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