General MedicationsRECTALStandard
INDOMETHACIN
INDOMETHACIN
Standard Dose
50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview INDOMETHACIN is listed in Drugs@FDA under application 216905 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient INDOMETHACIN Form and strength SUPPOSITORY;RECTAL - 50MG Sponsor ANNORA PHARMA Submission history Latest submission status date: 2025-07-03 00:00:00.
Structured Monograph
Clinical summary
Approval overview INDOMETHACIN is listed in Drugs@FDA under application 216905 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient INDOMETHACIN Form and strength SUPPOSITORY;RECTAL - 50MG Sponsor ANNORA PHARMA Submission history Latest submission status date: 2025-07-03 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.