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General MedicationsORALStandard

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

Standard Dose
20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ISOSORBIDE DINITRATE is listed in Drugs@FDA under application 215723 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ISOSORBIDE DINITRATE Form and strength TABLET;ORAL - 20MG Sponsor RUBICON Submission history Latest submission status date: 2022-07-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview ISOSORBIDE DINITRATE is listed in Drugs@FDA under application 215723 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ISOSORBIDE DINITRATE Form and strength TABLET;ORAL - 20MG Sponsor RUBICON Submission history Latest submission status date: 2022-07-08 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.