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General MedicationsORALStandard

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Standard Dose
10MG;6.25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 219489 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Form and strength TABLET;ORAL - 10MG;6.25MG Sponsor UNIQUE PHARM Submission history Latest submission status date: 2026-03-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 219489 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Form and strength TABLET;ORAL - 10MG;6.25MG Sponsor UNIQUE PHARM Submission history Latest submission status date: 2026-03-24 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.