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General MedicationsINTRAUTERINEStandard

MIUDELLA

COPPER

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

Approval overview MIUDELLA is listed in Drugs@FDA under application 218201 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient COPPER Form and strength SYSTEM;INTRAUTERINE - N/A Sponsor SEBELA WOMENS HLTH Submission history Latest submission status date: 2025-10-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview MIUDELLA is listed in Drugs@FDA under application 218201 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient COPPER Form and strength SYSTEM;INTRAUTERINE - N/A Sponsor SEBELA WOMENS HLTH Submission history Latest submission status date: 2025-10-01 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.