General MedicationsVAGINALStandard
ESTRADIOL
ESTRADIOL
Standard Dose
0.01%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ESTRADIOL is listed in Drugs@FDA under application 212313 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL Form and strength CREAM;VAGINAL - 0.01% Sponsor PRASCO Submission history Latest submission status date: 2025-05-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview ESTRADIOL is listed in Drugs@FDA under application 212313 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL Form and strength CREAM;VAGINAL - 0.01% Sponsor PRASCO Submission history Latest submission status date: 2025-05-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.