General MedicationsORALGeneric

PREFEST

ESTRADIOL; NORGESTIMATE

Standard Dose

1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 PREFEST is listed in Drugs@FDA under application 021040 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ESTRADIOL; NORGESTIMATE Form and strength TABLET;ORAL - 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TEVA WOMENS Submission history Latest submission status date: 2024-02-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview PREFEST is listed in Drugs@FDA under application 021040 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ESTRADIOL; NORGESTIMATE Form and strength TABLET;ORAL - 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TEVA WOMENS Submission history Latest submission status date: 2024-02-15 00:00:00.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.