General MedicationsCAPSULEStandard

SHEUR

ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX

Standard Dose

300MG/1MG/0.5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview SHEUR is listed in Drugs@FDA under application 217650 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX Form and strength CAPSULE - 300MG/1MG/0.5MG Sponsor TEVA PHARM Submission history Latest submission status date: 2025-09-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview SHEUR is listed in Drugs@FDA under application 217650 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX Form and strength CAPSULE - 300MG/1MG/0.5MG Sponsor TEVA PHARM Submission history Latest submission status date: 2025-09-22 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.