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General MedicationsTRANSDERMALStandard

CLIMARA PRO

ESTRADIOL; LEVONORGESTREL

Standard Dose
0.045MG/24HR;0.015MG/24HR
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview CLIMARA PRO is listed in Drugs@FDA under application 021258 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL; LEVONORGESTREL Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2024-02-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview CLIMARA PRO is listed in Drugs@FDA under application 021258 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL; LEVONORGESTREL Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR 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.