General MedicationsVAGINALStandard
PHEXXI
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
Standard Dose
1%;1.8%;0.4%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PHEXXI is listed in Drugs@FDA under application 208352 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE Form and strength GEL;VAGINAL - 1%;1.8%;0.4% Sponsor EVOFEM INC Submission history Latest submission status date: 2025-04-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview PHEXXI is listed in Drugs@FDA under application 208352 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE Form and strength GEL;VAGINAL - 1%;1.8%;0.4% Sponsor EVOFEM INC Submission history Latest submission status date: 2025-04-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.