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General MedicationsORALStandard

MONTELUKAST SODIUM

MONTELUKAST SODIUM

Standard Dose
EQ 4MG BASE/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MONTELUKAST SODIUM is listed in Drugs@FDA under application 213471 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MONTELUKAST SODIUM Form and strength GRANULE;ORAL - EQ 4MG BASE/PACKET Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2021-07-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview MONTELUKAST SODIUM is listed in Drugs@FDA under application 213471 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MONTELUKAST SODIUM Form and strength GRANULE;ORAL - EQ 4MG BASE/PACKET Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2021-07-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.