APPLICATION
ANDA076119
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-24
LATEST ACTION
2020-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MIRTAZAPINEPrescription
MIRTAZAPINE 30MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 45MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 15MG · TABLET · ORAL
Approval history
2020-02-24Labeling · Supplement 27 · standardAP
2020-02-24Labeling · Supplement 26 · standardAP
2020-02-24Labeling · Supplement 30 · standardAP
2014-10-24Labeling · Supplement 24 · standardAP
2013-01-31Labeling · Supplement 23 · standardAP
2013-01-31Labeling · Supplement 22AP
2010-07-19Labeling · Supplement 20AP
2007-11-06Labeling · Supplement 13AP
2007-11-06Labeling · Supplement 14AP
2006-07-21Labeling · Supplement 12AP
2005-07-12Labeling · Supplement 6AP
2004-12-29Labeling · Supplement 4AP
2003-06-19Labeling · Supplement 2AP
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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