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General MedicationsINJECTIONStandard

AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE

Standard Dose
50MG/ML
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 218253 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMIODARONE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 50MG/ML Sponsor ZHEJIANG POLY PHARM Submission history Latest submission status date: 2024-09-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMIODARONE HYDROCHLORIDE is listed in Drugs@FDA under application 218253 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMIODARONE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 50MG/ML Sponsor ZHEJIANG POLY PHARM Submission history Latest submission status date: 2024-09-11 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.