General MedicationsORALStandard
PROCYSBI
CYSTEAMINE BITARTRATE
Standard Dose
EQ 25MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Prescription
Summary
Approval overview PROCYSBI is listed in Drugs@FDA under application 203389 (NDA).
Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient CYSTEAMINE BITARTRATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE Sponsor HORIZON Submission history Latest submission status date: 2022-02-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview PROCYSBI is listed in Drugs@FDA under application 203389 (NDA). Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient CYSTEAMINE BITARTRATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE Sponsor HORIZON Submission history Latest submission status date: 2022-02-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: 901 REQUIRED
Interaction Notes
- No interaction notes stored yet.