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General MedicationsORALStandard

SDAMLO

AMLODIPINE BESYLATE

Standard Dose
EQ 5MG BASE/BOT
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SDAMLO is listed in Drugs@FDA under application 219531 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE Form and strength FOR SOLUTION;ORAL - EQ 5MG BASE/BOT Sponsor BRILLIAN PHARMA Submission history Latest submission status date: 2025-07-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview SDAMLO is listed in Drugs@FDA under application 219531 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE Form and strength FOR SOLUTION;ORAL - EQ 5MG BASE/BOT Sponsor BRILLIAN PHARMA Submission history Latest submission status date: 2025-07-24 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.