APPLICATION
ANDA076307
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-17
LATEST ACTION
2020-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
MIRTAZAPINEDiscontinued
MIRTAZAPINE 45MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 30MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2020-02-25Labeling · Supplement 22 · standardAP
2020-02-25Labeling · Supplement 20 · standardAP
2007-11-07Labeling · Supplement 11AP
2007-11-07Labeling · Supplement 14AP
2006-02-28Manufacturing (CMC) · Supplement 1AP
2006-02-28Labeling · Supplement 6AP
2006-02-28Labeling · Supplement 2AP
2006-02-28Manufacturing (CMC) · Supplement 7AP
2006-02-28Manufacturing (CMC) · Supplement 5AP
2005-07-14Labeling · Supplement 8AP
2004-11-23Labeling · Supplement 4AP
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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