Mirtazapine

ANDA 76689, held by Actavis Elizabeth. Mirtazapine.

As of Nov 15, 2026, ANDA 76689 (Mirtazapine), held by Actavis Elizabeth, was first approved by FDA on Aug 31, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 2005
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 31, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Mirtazapine15MG · tablet, orally disintegrating;oral	Mirtazapine	Discontinued
Mirtazapine30MG · tablet, orally disintegrating;oral	Mirtazapine	Discontinued
Mirtazapine45MG · tablet, orally disintegrating;oral	Mirtazapine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 23, 2008	Supplement 4Labeling	Approved	None posted
Aug 31, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76689
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