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General MedicationsORALGeneric

AMTURNIDE

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Standard Dose
EQ 300MG BASE;EQ 5MG BASE;12.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview AMTURNIDE is listed in Drugs@FDA under application 200045 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE Form and strength TABLET;ORAL - EQ 300MG BASE;EQ 5MG BASE;12.5MG Sponsor NOVARTIS Submission history Latest submission status date: 2016-11-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMTURNIDE is listed in Drugs@FDA under application 200045 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE Form and strength TABLET;ORAL - EQ 300MG BASE;EQ 5MG BASE;12.5MG Sponsor NOVARTIS Submission history Latest submission status date: 2016-11-04 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.