Mirtazapine

ANDA 76176, held by Pharmazone. Mirtazapine.

As of Nov 15, 2026, ANDA 76176 (Mirtazapine), held by Pharmazone, was first approved by FDA on Jun 19, 2003, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2003
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 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 8 submissions, including labeling and manufacturing supplements


Nov 29, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Jun 22, 2009	Supplement 8Labeling	Approved	None posted
Jan 2, 2009	Supplement 7Labeling	Approved	None posted
Oct 30, 2007	Supplement 6Labeling	Approved	None posted
Aug 23, 2005	Supplement 3Labeling	Approved	None posted
Aug 23, 2005	Supplement 4Labeling	Approved	None posted
Feb 9, 2005	Supplement 1Labeling	Approved	None posted
Jun 19, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76176
Drugs@FDA: Overview at FDA
Company: Pharmazone

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