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General MedicationsORAL-28Standard

PREMPHASE 14/14

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Standard Dose
0.625MG,0.625MG;N/A,5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PREMPHASE 14/14 is listed in Drugs@FDA under application 020527 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Form and strength TABLET;ORAL-28 - 0.625MG,0.625MG;N/A,5MG Sponsor WYETH PHARMS Submission history Latest submission status date: 2025-04-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview PREMPHASE 14/14 is listed in Drugs@FDA under application 020527 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Form and strength TABLET;ORAL-28 - 0.625MG,0.625MG;N/A,5MG Sponsor WYETH PHARMS Submission history Latest submission status date: 2025-04-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.