Mirtazapine

ANDA 76312, held by Watson Labs. Mirtazapine.

As of Nov 15, 2026, ANDA 76312 (Mirtazapine), held by Watson Labs, was first approved by FDA on Jun 19, 2003, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2003
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 19, 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 9 submissions, including labeling and manufacturing supplements


Oct 24, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Oct 23, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Dec 2, 2008	Supplement 7Labeling	Approved	None posted
Jun 3, 2008	Supplement 6Labeling	Approved	None posted
Nov 6, 2007	Supplement 5Labeling	Approved	None posted
Jan 29, 2007	Supplement 4Labeling	Approved	None posted
Aug 23, 2005	Supplement 3Labeling	Approved	None posted
Jan 21, 2005	Supplement 1Labeling	Approved	None posted
Jun 19, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76312
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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