General MedicationsORALStandard
ROFLUMILAST
ROFLUMILAST
Standard Dose
250MCG
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary
Approval overview ROFLUMILAST is listed in Drugs@FDA under application 213298 (ANDA).
Review priority: UNKNOWN Marketing status: Prescription Active ingredient ROFLUMILAST Form and strength TABLET;ORAL - 250MCG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-01-31 00:00:00.
Structured Monograph
Clinical summary
Approval overview ROFLUMILAST is listed in Drugs@FDA under application 213298 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient ROFLUMILAST Form and strength TABLET;ORAL - 250MCG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-01-31 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: UNKNOWN
Interaction Notes
- No interaction notes stored yet.