Mirtazapine

ANDA 76307, held by Actavis Labs Fl Inc. Mirtazapine.

As of Nov 15, 2026, ANDA 76307 (Mirtazapine), held by Actavis Labs Fl Inc, was first approved by FDA on Dec 17, 2003, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2003
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 17, 2003	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 12 submissions, including labeling and manufacturing supplements


Feb 25, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Feb 25, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Nov 7, 2007	Supplement 11Labeling	Approved	None posted
Nov 7, 2007	Supplement 14Labeling	Approved	None posted
Feb 28, 2006	Supplement 1Manufacturing	Approved	None posted
Feb 28, 2006	Supplement 2Labeling	Approved	None posted
Feb 28, 2006	Supplement 5Manufacturing	Approved	None posted
Feb 28, 2006	Supplement 6Labeling	Approved	None posted
Feb 28, 2006	Supplement 7Manufacturing	Approved	None posted
Jul 14, 2005	Supplement 8Labeling	Approved	None posted
Nov 23, 2004	Supplement 4Labeling	Approved	None posted
Dec 17, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76307
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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