Mirtazapine

ANDA 76308, held by Actavis Elizabeth. Mirtazapine.

As of Nov 15, 2026, ANDA 76308 (Mirtazapine), held by Actavis Elizabeth, was first approved by FDA on Jun 20, 2003, with 0 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first

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

Identifiers

Application: ANDA 76308
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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