General MedicationsORALStandard
ALKINDI SPRINKLE
HYDROCORTISONE
Standard Dose
0.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ALKINDI SPRINKLE is listed in Drugs@FDA under application 213876 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCORTISONE Form and strength GRANULE;ORAL - 0.5MG Sponsor ETON Submission history Latest submission status date: 2024-06-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview ALKINDI SPRINKLE is listed in Drugs@FDA under application 213876 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCORTISONE Form and strength GRANULE;ORAL - 0.5MG Sponsor ETON Submission history Latest submission status date: 2024-06-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.