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General MedicationsORALGeneric

PRESTALIA

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Standard Dose
EQ 10MG BASE;14MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview PRESTALIA is listed in Drugs@FDA under application 205003 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient AMLODIPINE BESYLATE; PERINDOPRIL ARGININE Form and strength TABLET;ORAL - EQ 10MG BASE;14MG Sponsor ADHERA Submission history Latest submission status date: 2017-09-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview PRESTALIA is listed in Drugs@FDA under application 205003 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMLODIPINE BESYLATE; PERINDOPRIL ARGININE Form and strength TABLET;ORAL - EQ 10MG BASE;14MG Sponsor ADHERA Submission history Latest submission status date: 2017-09-29 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.