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General MedicationsINTRAVENOUSStandard

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

MOXIFLOXACIN HYDROCHLORIDE

Standard Dose
400MG/250ML (1.6MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is listed in Drugs@FDA under application 205833 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MOXIFLOXACIN HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2023-05-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is listed in Drugs@FDA under application 205833 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MOXIFLOXACIN HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2023-05-19 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.