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General MedicationsORALStandard

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

Standard Dose
400MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMIODARONE HYDROCHLORIDE is listed in Drugs@FDA under application 079029 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMIODARONE HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2019-10-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMIODARONE HYDROCHLORIDE is listed in Drugs@FDA under application 079029 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMIODARONE HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2019-10-29 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.