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General MedicationsINJECTIONStandard

AMIKACIN SULFATE

AMIKACIN SULFATE

Standard Dose
500MG(BASE)/ML(250MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMIKACIN SULFATE is listed in Drugs@FDA under application 203323 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMIKACIN SULFATE Form and strength INJECTABLE;INJECTION - 500MG(BASE)/ML(250MG/ML) Sponsor SAGENT PHARMS INC Submission history Latest submission status date: 2023-02-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMIKACIN SULFATE is listed in Drugs@FDA under application 203323 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMIKACIN SULFATE Form and strength INJECTABLE;INJECTION - 500MG(BASE)/ML(250MG/ML) Sponsor SAGENT PHARMS INC Submission history Latest submission status date: 2023-02-10 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.