General MedicationsVAGINALStandard
HALOETTE
ETHINYL ESTRADIOL; ETONOGESTREL
Standard Dose
0.015MG/24HR;0.12MG/24HR
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview HALOETTE is listed in Drugs@FDA under application 211328 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; ETONOGESTREL Form and strength RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2025-01-08 00:00:00.
Structured Monograph
Clinical summary
Approval overview HALOETTE is listed in Drugs@FDA under application 211328 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; ETONOGESTREL Form and strength RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2025-01-08 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.