APPLICATION
ANDA206098
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-10
LATEST ACTION
2025-05-27
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ASENAPINE MALEATEPrescription
ASENAPINE MALEATE EQ 10MG BASE · TABLET · SUBLINGUAL
ASENAPINE MALEATEPrescription
ASENAPINE MALEATE EQ 2.5MG BASE · TABLET · SUBLINGUAL
ASENAPINE MALEATEPrescription
ASENAPINE MALEATE EQ 5MG BASE · TABLET · SUBLINGUAL
Approval history
2025-05-27Labeling · Supplement 12 · standardAP
2021-07-19Manufacturing (CMC) · Supplement 2 · unknownAP
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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