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General MedicationsORALStandard

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Standard Dose
EQ 5MG BASE;20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is listed in Drugs@FDA under application 202239 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 5MG BASE;20MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2023-03-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is listed in Drugs@FDA under application 202239 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 5MG BASE;20MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2023-03-15 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.