General MedicationsORALStandard

DIROXIMEL FUMARATE

Standard Dose

231MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DIROXIMEL FUMARATE is listed in Drugs@FDA under application 218596 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DIROXIMEL FUMARATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - 231MG Sponsor ZYDUS Submission history Latest submission status date: 2025-11-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview DIROXIMEL FUMARATE is listed in Drugs@FDA under application 218596 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIROXIMEL FUMARATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - 231MG Sponsor ZYDUS Submission history Latest submission status date: 2025-11-12 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.