General MedicationsRECTALStandard
MESALAMINE
MESALAMINE
Standard Dose
1GM
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 219028 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient MESALAMINE Form and strength SUPPOSITORY;RECTAL - 1GM Sponsor RISING Submission history Latest submission status date: 2025-04-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview MESALAMINE is listed in Drugs@FDA under application 219028 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MESALAMINE Form and strength SUPPOSITORY;RECTAL - 1GM Sponsor RISING Submission history Latest submission status date: 2025-04-14 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.