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General MedicationsORALStandard

RISEDRONATE SODIUM

RISEDRONATE SODIUM

Standard Dose
5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview RISEDRONATE SODIUM is listed in Drugs@FDA under application 203533 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RISEDRONATE SODIUM Form and strength TABLET;ORAL - 5MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2024-05-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview RISEDRONATE SODIUM is listed in Drugs@FDA under application 203533 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RISEDRONATE SODIUM Form and strength TABLET;ORAL - 5MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2024-05-23 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.