Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALStandard

ORIAHNN (COPACKAGED)

ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Standard Dose
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ORIAHNN (COPACKAGED) is listed in Drugs@FDA under application 213388 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM Form and strength CAPSULE;ORAL - EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE Sponsor ABBVIE Submission history Latest submission status date: 2025-12-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview ORIAHNN (COPACKAGED) is listed in Drugs@FDA under application 213388 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM Form and strength CAPSULE;ORAL - EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE Sponsor ABBVIE Submission history Latest submission status date: 2025-12-17 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.