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General MedicationsORALStandard

BUCAPSOL

BUSPIRONE HYDROCHLORIDE

Standard Dose
7.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BUCAPSOL is listed in Drugs@FDA under application 218628 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUSPIRONE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 7.5MG Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2025-10-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUCAPSOL is listed in Drugs@FDA under application 218628 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUSPIRONE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 7.5MG Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2025-10-17 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.