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General MedicationsORALStandard

ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Standard Dose
37.5MG;20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary

Approval overview ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is listed in Drugs@FDA under application 215988 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE Form and strength TABLET;ORAL - 37.5MG;20MG Sponsor I3 PHARMS Submission history Latest submission status date: 2024-01-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is listed in Drugs@FDA under application 215988 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE Form and strength TABLET;ORAL - 37.5MG;20MG Sponsor I3 PHARMS Submission history Latest submission status date: 2024-01-30 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: UNKNOWN

Interaction Notes

  • No interaction notes stored yet.