Mirtazapine

ANDA 76241, held by Actavis Elizabeth. Mirtazapine.

As of Nov 15, 2026, ANDA 76241 (Mirtazapine), held by Actavis Elizabeth, was first approved by FDA on Jun 25, 2003, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 25, 2003
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 25, 2003	Original application	Approved	Review

Products

3 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Jul 11, 2008	Supplement 12Labeling	Approved	None posted
Oct 30, 2007	Supplement 9Labeling	Approved	None posted
Mar 23, 2007	Supplement 7Labeling	Approved	None posted
Jul 21, 2006	Supplement 6Labeling	Approved	None posted
Jul 12, 2005	Supplement 5Labeling	Approved	None posted
Dec 29, 2004	Supplement 3Labeling	Approved	None posted
Oct 22, 2003	Supplement 1Labeling	Approved	None posted
Jun 25, 2003	Original application	Approved	Review

Identifiers

Application: ANDA 76241
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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