Mirtazapine

ANDA 76244, held by Ivax Sub Teva Pharms. Mirtazapine.

As of Nov 15, 2026, ANDA 76244 (Mirtazapine), held by Ivax Sub Teva Pharms, was first approved by FDA on Dec 22, 2003, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 22, 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
Dec 22, 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 8, 2006	Supplement 9Labeling	Approved	None posted
Sep 26, 2005	Supplement 8Labeling	Approved	None posted
Mar 1, 2005	Supplement 6Labeling	Approved	None posted
Feb 22, 2005	Supplement 2Labeling	Approved	None posted
Dec 22, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76244
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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