General MedicationsORALStandard
PREDNISOLONE
PREDNISOLONE
Standard Dose
15MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PREDNISOLONE is listed in Drugs@FDA under application 219509 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PREDNISOLONE Form and strength SOLUTION;ORAL - 15MG/5ML Sponsor TP ANDA HOLDINGS Submission history Latest submission status date: 2025-06-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview PREDNISOLONE is listed in Drugs@FDA under application 219509 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PREDNISOLONE Form and strength SOLUTION;ORAL - 15MG/5ML Sponsor TP ANDA HOLDINGS Submission history Latest submission status date: 2025-06-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.