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General MedicationsORALStandard

SUMATRIPTAN AND NAPROXEN SODIUM

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Standard Dose
500MG;EQ 85MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SUMATRIPTAN AND NAPROXEN SODIUM is listed in Drugs@FDA under application 207457 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE Form and strength TABLET;ORAL - 500MG;EQ 85MG BASE Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2020-06-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUMATRIPTAN AND NAPROXEN SODIUM is listed in Drugs@FDA under application 207457 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE Form and strength TABLET;ORAL - 500MG;EQ 85MG BASE Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2020-06-24 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.