← FDA DRUG APPROVALS

FDA NDA · NDA020415

REMERON

mirtazapine

Sponsor: ORGANON

APPLICATION
NDA020415
TYPE
NDA
ORIGINAL APPROVAL
1996-06-14
LATEST ACTION
2025-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

REMERON · ReferencePrescription
MIRTAZAPINE 30MG · TABLET · ORAL
REMERON · ReferenceDiscontinued
MIRTAZAPINE 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
REMERON · ReferencePrescription
MIRTAZAPINE 15MG · TABLET · ORAL

Approval history

2025-07-23Manufacturing (CMC) · Supplement 39 · standard — Letter ↗AP
2021-11-18Labeling · Supplement 38 · standard — Label ↗AP
2020-04-29Labeling · Supplement 36 · standard — Letter ↗AP
2020-04-29Labeling · Supplement 34 · standard — Letter ↗AP
2020-03-04Labeling · Supplement 29 · standard — Label ↗AP
2019-09-05Labeling · Supplement 35 · standard — Label ↗AP
2016-07-08Labeling · Supplement 30 · standard — Label ↗AP
2015-12-30Labeling · Supplement 32 · standard — Label ↗AP
2014-09-30Manufacturing (CMC) · Supplement 28 · standardAP
2014-07-18Labeling · Supplement 31 · 901 required — Label ↗AP
2012-12-11Manufacturing (CMC) · Supplement 27 · standardAP
2012-10-30Labeling · Supplement 26 · standard — Label ↗AP
2011-12-27Labeling · Supplement 22 · standard — Letter ↗AP
2010-05-14Labeling · Supplement 23 · unknown — Label ↗AP
2010-05-14Labeling · Supplement 24 · unknown — Label ↗AP
2007-07-30Labeling · Supplement 19 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 18 · standard — Label ↗AP
2004-06-01Labeling · Supplement 16 · standard — Letter ↗AP
2002-09-30Labeling · Supplement 15 · standard — Letter ↗AP
2002-04-09Efficacy · Supplement 9 · standard — Letter ↗AP
2001-11-20Manufacturing (CMC) · Supplement 14 · standardAP
2001-01-26Manufacturing (CMC) · Supplement 10 · standardAP
2000-08-30Labeling · Supplement 6 · standardAP
2000-07-19Manufacturing (CMC) · Supplement 8 · standardAP
2000-02-28Labeling · Supplement 7 · standardAP
1999-05-11Manufacturing (CMC) · Supplement 5 · standardAP
1998-04-09Manufacturing (CMC) · Supplement 4 · standardAP
1997-03-17Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1996-11-07Manufacturing (CMC) · Supplement 2 · standardAP
1996-11-04Manufacturing (CMC) · Supplement 1 · standardAP
1996-06-14Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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