General MedicationsSUBLINGUALStandard

ASENAPINE MALEATE

Standard Dose

EQ 2.5MG 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 206098 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ASENAPINE MALEATE Form and strength TABLET;SUBLINGUAL - EQ 2.5MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2025-05-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview ASENAPINE MALEATE is listed in Drugs@FDA under application 206098 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ASENAPINE MALEATE Form and strength TABLET;SUBLINGUAL - EQ 2.5MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2025-05-27 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.