Mirtazapine

ANDA 76336, held by Actavis Labs Fl Inc. Mirtazapine.

As of Nov 15, 2026, ANDA 76336 (Mirtazapine), held by Actavis Labs Fl Inc, was first approved by FDA on Jun 20, 2003, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2003
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 20, 2003	Original application	Approved	None posted

Products

3 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 5, 2007	Supplement 7Labeling	Approved	None posted
Nov 6, 2006	Supplement 6Labeling	Approved	None posted
Apr 28, 2005	Supplement 5Labeling	Approved	None posted
Apr 28, 2005	Supplement 3Labeling	Approved	None posted
Jun 20, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76336
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