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CardiovascularORALStandard

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Standard Dose
EQ 2.5MG BASE;EQ 40MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is listed in Drugs@FDA under application 217279 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM Form and strength TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2025-05-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is listed in Drugs@FDA under application 217279 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM Form and strength TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2025-05-22 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.