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General MedicationsORALStandard

RAYALDEE

CALCIFEDIOL

Standard Dose
0.03MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview RAYALDEE is listed in Drugs@FDA under application 208010 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient CALCIFEDIOL Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 0.03MG Sponsor EIRGEN Submission history Latest submission status date: 2024-01-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview RAYALDEE is listed in Drugs@FDA under application 208010 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient CALCIFEDIOL Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 0.03MG Sponsor EIRGEN Submission history Latest submission status date: 2024-01-19 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.