APPLICATION
ANDA076921
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-22
LATEST ACTION
2022-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MIRTAZAPINEPrescription
MIRTAZAPINE 45MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 15MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 30MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 7.5MG · TABLET · ORAL
Approval history
2022-09-15Labeling · Supplement 41 · standardAP
2021-07-06Labeling · Supplement 38 · standardAP
2021-07-06Labeling · Supplement 36 · standardAP
2019-11-22Labeling · Supplement 29 · standardAP
2019-11-22Labeling · Supplement 35 · standardAP
2019-11-22Labeling · Supplement 30 · standardAP
2015-01-16Labeling · Supplement 26 · standardAP
2013-01-31Labeling · Supplement 23AP
2013-01-31Labeling · Supplement 24 · standardAP
2011-06-06Labeling · Supplement 15AP
2010-12-30Labeling · Supplement 20AP
2007-11-26Labeling · Supplement 11AP
2007-11-26Labeling · Supplement 10AP
2007-08-21Labeling · Supplement 8AP
2007-04-09Labeling · Supplement 4AP
2007-01-16Labeling · Supplement 5AP
2006-07-21Labeling · Supplement 2AP
2005-12-28Labeling · 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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