General MedicationsCAPSULEGeneric

LUMATEPERONE TOSYLATE

Standard Dose

28MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview LUMATEPERONE TOSYLATE is listed in Drugs@FDA under application 219248 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LUMATEPERONE TOSYLATE Form and strength CAPSULE - 28MG Sponsor MSN LABORATORIES PRIVATE LTD Submission history Latest submission status date: 2025-05-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUMATEPERONE TOSYLATE is listed in Drugs@FDA under application 219248 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LUMATEPERONE TOSYLATE Form and strength CAPSULE - 28MG Sponsor MSN LABORATORIES PRIVATE LTD Submission history Latest submission status date: 2025-05-01 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.