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General MedicationsORALGeneric

ONMEL

ITRACONAZOLE

Standard Dose
200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ONMEL is listed in Drugs@FDA under application 022484 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ITRACONAZOLE Form and strength TABLET;ORAL - 200MG Sponsor SEBELA IRELAND LTD Submission history Latest submission status date: 2010-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview ONMEL is listed in Drugs@FDA under application 022484 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ITRACONAZOLE Form and strength TABLET;ORAL - 200MG Sponsor SEBELA IRELAND LTD Submission history Latest submission status date: 2010-04-29 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.