General MedicationsORALStandard
DIPENTUM
OLSALAZINE SODIUM
Standard Dose
250MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DIPENTUM is listed in Drugs@FDA under application 019715 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient OLSALAZINE SODIUM Form and strength CAPSULE;ORAL - 250MG Sponsor MYLAN SPCLT VIATRIS Submission history Latest submission status date: 2024-07-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview DIPENTUM is listed in Drugs@FDA under application 019715 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OLSALAZINE SODIUM Form and strength CAPSULE;ORAL - 250MG Sponsor MYLAN SPCLT VIATRIS Submission history Latest submission status date: 2024-07-30 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.