APPLICATION
ANDA205798
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-01
LATEST ACTION
2023-12-06
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
MIRTAZAPINEPrescription
MIRTAZAPINE 45MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 30MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-12-06Labeling · Supplement 2 · standardAP
2020-10-16Labeling · Supplement 1 · standardAP
2017-06-01UNKNOWN · Original · standardAP
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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