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General MedicationsVAGINALGeneric

VAGIFEM

ESTRADIOL

Standard Dose
25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview VAGIFEM is listed in Drugs@FDA under application 020908 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ESTRADIOL Form and strength TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor NOVO NORDISK INC Submission history Latest submission status date: 2024-02-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview VAGIFEM is listed in Drugs@FDA under application 020908 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ESTRADIOL Form and strength TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor NOVO NORDISK INC Submission history Latest submission status date: 2024-02-15 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.