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General MedicationsORALStandard

CLARINEX-D 12 HOUR

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Standard Dose
2.5MG;120MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview CLARINEX-D 12 HOUR is listed in Drugs@FDA under application 021313 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DESLORATADINE; PSEUDOEPHEDRINE SULFATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG Sponsor ORGANON LLC Submission history Latest submission status date: 2019-03-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview CLARINEX-D 12 HOUR is listed in Drugs@FDA under application 021313 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DESLORATADINE; PSEUDOEPHEDRINE SULFATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG Sponsor ORGANON LLC Submission history Latest submission status date: 2019-03-15 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.