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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.