Nalfon

NDA 17710, held by Dista. Fenoprofen Calcium.

As of Nov 13, 2026, NDA 17710 (Nalfon), held by Dista, was first approved by FDA on Jun 9, 1977, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 9, 1977
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jun 9, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
NalfonEQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fenoprofen Calcium	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 22, 1997	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 29, 1995	Supplement 21Labeling · Standard review	Approved	None posted
Apr 25, 1994	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 4, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 8, 1988	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 11, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 8, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 8, 1987	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 9, 1986	Supplement 12Labeling · Standard review	Approved	None posted
Aug 9, 1983	Supplement 4Labeling · Standard review	Approved	None posted
Aug 9, 1983	Supplement 7Labeling · Standard review	Approved	None posted
Mar 31, 1983	Supplement 10Labeling · Standard review	Approved	None posted
Feb 10, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 10, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 9, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 9, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17710
Drugs@FDA: Overview at FDA
Company: Dista Products

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters