General MedicationsSUBLINGUALStandard

ASENAPINE MALEATE

Standard Dose

EQ 10MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ASENAPINE MALEATE is listed in Drugs@FDA under application 206107 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ASENAPINE MALEATE Form and strength TABLET;SUBLINGUAL - EQ 10MG BASE Sponsor SIGMAPHARM LABS LLC Submission history Latest submission status date: 2026-03-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview ASENAPINE MALEATE is listed in Drugs@FDA under application 206107 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ASENAPINE MALEATE Form and strength TABLET;SUBLINGUAL - EQ 10MG BASE Sponsor SIGMAPHARM LABS LLC Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.