General MedicationsORALStandard
ANGELIQ
DROSPIRENONE; ESTRADIOL
Standard Dose
0.25MG;0.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ANGELIQ is listed in Drugs@FDA under application 021355 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ESTRADIOL Form and strength TABLET;ORAL - 0.25MG;0.5MG Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2024-02-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview ANGELIQ is listed in Drugs@FDA under application 021355 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ESTRADIOL Form and strength TABLET;ORAL - 0.25MG;0.5MG Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2024-02-15 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.