General MedicationsORALStandard

MESALAMINE

Standard Dose

1.2GM

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview MESALAMINE is listed in Drugs@FDA under application 217337 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MESALAMINE Form and strength TABLET, DELAYED RELEASE;ORAL - 1.2GM Sponsor SINOTHERAPEUTICS INC Submission history Latest submission status date: 2025-05-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview MESALAMINE is listed in Drugs@FDA under application 217337 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MESALAMINE Form and strength TABLET, DELAYED RELEASE;ORAL - 1.2GM Sponsor SINOTHERAPEUTICS INC Submission history Latest submission status date: 2025-05-29 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.