General MedicationsIMPLANTATIONGeneric

JADELLE

LEVONORGESTREL

Standard Dose

75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 JADELLE is listed in Drugs@FDA under application 020544 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient LEVONORGESTREL Form and strength IMPLANT;IMPLANTATION - 75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor POPULATION COUNCIL Submission history Latest submission status date: 2016-12-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview JADELLE is listed in Drugs@FDA under application 020544 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient LEVONORGESTREL Form and strength IMPLANT;IMPLANTATION - 75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor POPULATION COUNCIL Submission history Latest submission status date: 2016-12-20 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.