General MedicationsORALGeneric

LYBREL

ETHINYL ESTRADIOL; LEVONORGESTREL

Standard Dose

0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 LYBREL is listed in Drugs@FDA under application 021864 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor WYETH PHARMS INC Submission history Latest submission status date: 2016-06-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview LYBREL is listed in Drugs@FDA under application 021864 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor WYETH PHARMS INC Submission history Latest submission status date: 2016-06-16 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.