← FDA DRUG APPROVALS

FDA ANDA · ANDA076901

MIRTAZAPINE

Sponsor: IMPAX LABS INC

APPLICATION
ANDA076901
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-28
LATEST ACTION
2025-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

MIRTAZAPINEDiscontinued
MIRTAZAPINE 45MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 30MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2025-07-16Labeling · Supplement 17 · standardAP
2025-07-16Labeling · Supplement 16 · standardAP
2025-07-16Labeling · Supplement 14 · standardAP
2015-09-10Labeling · Supplement 13 · standardAP
2015-03-18Manufacturing (CMC) · Supplement 12 · unknownAP
2013-01-31Labeling · Supplement 7AP
2013-01-31Labeling · Supplement 11 · standardAP
2010-07-19Labeling · Supplement 6AP
2007-11-13Labeling · Supplement 5AP
2007-11-13Labeling · Supplement 3AP
2005-06-28Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →