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General MedicationsORALStandard

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Standard Dose
EQ 20MG BASE;375MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is listed in Drugs@FDA under application 217738 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESOMEPRAZOLE MAGNESIUM; NAPROXEN Form and strength TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2024-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is listed in Drugs@FDA under application 217738 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESOMEPRAZOLE MAGNESIUM; NAPROXEN Form and strength TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.