Mirtazapine

ANDA 76270, held by Roxane. Mirtazapine.

As of Nov 15, 2026, ANDA 76270 (Mirtazapine), held by Roxane, was first approved by FDA on Jun 19, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2003
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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 3 submissions, including labeling and manufacturing supplements


Dec 28, 2005	Supplement 2Labeling	Approved	None posted
Mar 18, 2005	Supplement 1Labeling	Approved	None posted
Jun 19, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76270
Drugs@FDA: Overview at FDA
Company: Roxane 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