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FDA ANDA · ANDA216751

MIRTAZAPINE

Sponsor: PRASCO

APPLICATION
ANDA216751
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-18
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MIRTAZAPINEPrescription
MIRTAZAPINE 30MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 7.5MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 45MG · TABLET · ORAL
MIRTAZAPINEPrescription
MIRTAZAPINE 15MG · TABLET · ORAL

Approval history

2023-06-28Labeling · Supplement 1 · standardAP
2023-01-18UNKNOWN · Original · standardAP
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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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