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FDA ANDA · ANDA206107

ASENAPINE

Sponsor: SIGMAPHARM LABS LLC

APPLICATION
ANDA206107
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-10
LATEST ACTION
2026-03-27
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ASENAPINE MALEATEPrescription
ASENAPINE MALEATE EQ 10MG BASE · TABLET · SUBLINGUAL
ASENAPINE MALEATEPrescription
ASENAPINE MALEATE EQ 5MG BASE · TABLET · SUBLINGUAL

Approval history

2026-03-27Labeling · Supplement 5 · standardAP
2020-12-10UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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