← FDA DRUG APPROVALS

FDA ANDA · ANDA076219

MIRTAZAPINE

Sponsor: CHARTWELL RX

APPLICATION
ANDA076219
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-19
LATEST ACTION
2022-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MIRTAZAPINEPrescription
MIRTAZAPINE 45MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 15MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 30MG · TABLET · ORAL

Approval history

2022-09-23Labeling · Supplement 28 · standardAP
2021-08-04Labeling · Supplement 26 · standardAP
2021-08-04Labeling · Supplement 27 · standardAP
2020-02-25Labeling · Supplement 24 · standardAP
2020-02-25Labeling · Supplement 25 · standardAP
2015-01-20Labeling · Supplement 23 · standardAP
2013-08-23Labeling · Supplement 20 · standardAP
2012-05-01Labeling · Supplement 14AP
2012-05-01Labeling · Supplement 15AP
2007-11-05Labeling · Supplement 12AP
2007-11-05Labeling · Supplement 10AP
2006-07-21Labeling · Supplement 5AP
2005-09-26Labeling · Supplement 3AP
2004-12-29Labeling · Supplement 2AP
2003-06-19Original — 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 →