General MedicationsVAGINALStandard
INTRAROSA
PRASTERONE
Standard Dose
6.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview INTRAROSA is listed in Drugs@FDA under application 208470 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PRASTERONE Form and strength INSERT;VAGINAL - 6.5MG Sponsor MILLICENT Submission history Latest submission status date: 2018-02-13 00:00:00.
Structured Monograph
Clinical summary
Approval overview INTRAROSA is listed in Drugs@FDA under application 208470 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PRASTERONE Form and strength INSERT;VAGINAL - 6.5MG Sponsor MILLICENT Submission history Latest submission status date: 2018-02-13 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.