General MedicationsTRANSDERMALStandard
TWIRLA
ETHINYL ESTRADIOL; LEVONORGESTREL
Standard Dose
0.03MG/24HR;0.12MG/24HR
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TWIRLA is listed in Drugs@FDA under application 204017 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength SYSTEM;TRANSDERMAL - 0.03MG/24HR;0.12MG/24HR Sponsor AGILE Submission history Latest submission status date: 2022-04-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview TWIRLA is listed in Drugs@FDA under application 204017 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength SYSTEM;TRANSDERMAL - 0.03MG/24HR;0.12MG/24HR Sponsor AGILE Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.