General MedicationsORALStandard

NAPROXEN SODIUM

Standard Dose

EQ 375MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview NAPROXEN SODIUM is listed in Drugs@FDA under application 075416 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NAPROXEN SODIUM Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2024-08-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview NAPROXEN SODIUM is listed in Drugs@FDA under application 075416 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NAPROXEN SODIUM Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2024-08-22 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.