APPLICATION
ANDA076541
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-22
LATEST ACTION
2022-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MIRTAZAPINEPrescription
MIRTAZAPINE 7.5MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 30MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 45MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 15MG · TABLET · ORAL
Approval history
2022-09-15Labeling · Supplement 27 · standardAP
2020-09-25Labeling · Supplement 26 · standardAP
2020-09-25Labeling · Supplement 25 · standardAP
2019-11-20Labeling · Supplement 24 · standardAP
2016-10-17Labeling · Supplement 20 · standardAP
2016-10-17Labeling · Supplement 21 · standardAP
2015-06-17Manufacturing (CMC) · Supplement 18 · unknownAP
2008-06-03Labeling · Supplement 11AP
2007-11-07Labeling · Supplement 10AP
2007-10-29Labeling · Supplement 9AP
2007-03-26Labeling · Supplement 8AP
2005-07-12Labeling · Supplement 4AP
2005-07-12Labeling · Supplement 5AP
2005-03-10Labeling · Supplement 2AP
2005-03-10Labeling · Supplement 3AP
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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