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General MedicationsTRANSDERMALStandard

ESTRADIOL

ESTRADIOL

Standard Dose
0.1% (0.5GM/PACKET)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ESTRADIOL is listed in Drugs@FDA under application 218507 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL Form and strength GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET) Sponsor ENCUBE Submission history Latest submission status date: 2025-03-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESTRADIOL is listed in Drugs@FDA under application 218507 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL Form and strength GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET) Sponsor ENCUBE Submission history Latest submission status date: 2025-03-05 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.