APPLICATION
ANDA076122
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-19
LATEST ACTION
2022-09-15
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
2022-09-15Labeling · Supplement 29 · standardAP
2020-11-04Labeling · Supplement 26 · standardAP
2020-11-04Labeling · Supplement 27 · standardAP
2019-11-22Labeling · Supplement 24 · standardAP
2019-11-22Labeling · Supplement 22 · standardAP
2019-11-22Labeling · Supplement 25 · standardAP
2015-08-27Labeling · Supplement 21 · standardAP
2014-03-18Labeling · Supplement 17 · standardAP
2011-06-28Labeling · Supplement 14AP
2007-11-06Labeling · Supplement 10AP
2007-11-06Labeling · Supplement 9AP
2005-09-26Labeling · Supplement 2AP
2004-12-29Labeling · Supplement 1AP
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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