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General MedicationsORALGeneric

MONOPRIL-HCT

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Standard Dose
10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview MONOPRIL-HCT is listed in Drugs@FDA under application 020286 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE Form and strength TABLET;ORAL - 10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2009-02-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview MONOPRIL-HCT is listed in Drugs@FDA under application 020286 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE Form and strength TABLET;ORAL - 10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2009-02-09 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.