NAPRELANnaproxen sodium

FDA approved the original new drug application for NAPRELAN on January 5, 1996, sponsored by TWI PHARMS. FDA’s record shows no approved efficacy supplement on the application since.

Application

NDA020353

Sponsor

TWI PHARMS

Original approval

January 5, 1996

Review

standard review

Submission class

Type 3 - New Dosage Form

Active ingredient

naproxen sodium

Browse every approval whose brand starts with N, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 14 · Labeling 10. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to TWI PHARMS

• November 10, 2011FORFIVO XLNDA022497
• October 6, 2011FLUOXETINE HYDROCHLORIDENDA202133
• May 19, 1988ZESTRILNDA019777
• June 8, 1984TENORETIC 100NDA018760
• August 19, 1981TENORMINNDA018240