General MedicationsORALStandard

ESLICARBAZEPINE ACETATE

Standard Dose

800MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ESLICARBAZEPINE ACETATE is listed in Drugs@FDA under application 211247 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESLICARBAZEPINE ACETATE Form and strength TABLET;ORAL - 800MG Sponsor SPH ZHONGXI PHARM Submission history Latest submission status date: 2025-11-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESLICARBAZEPINE ACETATE is listed in Drugs@FDA under application 211247 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESLICARBAZEPINE ACETATE Form and strength TABLET;ORAL - 800MG Sponsor SPH ZHONGXI PHARM Submission history Latest submission status date: 2025-11-03 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.