General MedicationsORALStandard
NAPROXEN
NAPROXEN
Standard Dose
375MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview NAPROXEN is listed in Drugs@FDA under application 218497 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient NAPROXEN Form and strength TABLET, DELAYED RELEASE;ORAL - 375MG Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2024-10-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview NAPROXEN is listed in Drugs@FDA under application 218497 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NAPROXEN Form and strength TABLET, DELAYED RELEASE;ORAL - 375MG Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2024-10-25 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.