General MedicationsORALGeneric

ETHINYL ESTRADIOL; LEVONORGESTREL

Standard Dose

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview ETHINYL ESTRADIOL; LEVONORGESTREL is listed in Drugs@FDA under application 206201 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A Sponsor MAYNE PHARMA INC Submission history Latest submission status date: 2017-04-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview ETHINYL ESTRADIOL; LEVONORGESTREL is listed in Drugs@FDA under application 206201 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A Sponsor MAYNE PHARMA INC Submission history Latest submission status date: 2017-04-28 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.