APPLICATION
ANDA077666
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-22
LATEST ACTION
2021-01-07
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
2021-01-07Labeling · Supplement 14 · standardAP
2019-11-22Labeling · Supplement 13 · standardAP
2019-11-22Labeling · Supplement 11 · standardAP
2019-11-22Labeling · Supplement 10 · standardAP
2015-12-03Labeling · Supplement 9 · standardAP
2013-08-29Labeling · Supplement 6 · standardAP
2013-08-29Labeling · Supplement 7 · standardAP
2011-06-28Labeling · Supplement 5AP
2009-06-22Labeling · Supplement 3AP
2007-11-06Labeling · Supplement 1AP
2007-08-22OriginalAP
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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