Tilade

NDA 19660, held by King Pharms LLC. Nedocromil Sodium.

As of Nov 14, 2026, NDA 19660 (Tilade), held by King Pharms LLC, was first approved by FDA on Dec 30, 1992, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1992
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Mar 6, 1997	Supplement 15Efficacy (new indication or use) · Standard review	Approved	None posted
May 18, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Dec 30, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tilade1.75MG/INH · aerosol, metered;inhalation	Nedocromil Sodium	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Feb 11, 2004	Supplement 17Labeling · Standard review	Approved	Letter
Jan 30, 1998	Supplement 16Labeling · Standard review	Approved	None posted
Mar 6, 1997	Supplement 15Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 26, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 4, 1996	Supplement 11Labeling · Standard review	Approved	None posted
Dec 27, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 27, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 20, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 7, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 20, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 1, 1994	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 16, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
May 3, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 28, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
May 19, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
May 18, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Dec 30, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19660
Drugs@FDA: Overview at FDA
Company: King Pharmaceuticals

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