Intal

NDA 18887, held by King Pharms LLC. Cromolyn Sodium.

As of Nov 13, 2026, NDA 18887 (Intal), held by King Pharms LLC, was first approved by FDA on Dec 5, 1985, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 5, 1985
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 5, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Intal0.8MG/INH · aerosol, metered;inhalation	Cromolyn Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Feb 11, 2004	Supplement 20Labeling · Standard review	Approved	Label Letter
Jul 23, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Dec 27, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 21, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 25, 1993	Supplement 14Labeling · Standard review	Approved	None posted
Apr 15, 1988	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 2Labeling	Approved	None posted
Dec 5, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18887
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