General MedicationsORAL-28Standard

PREMPRO

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Standard Dose

0.625MG;2.5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview PREMPRO 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;2.5MG Sponsor WYETH PHARMS Submission history Latest submission status date: 2025-04-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview PREMPRO 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;2.5MG 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.