Intal

NDA 18596, held by King Pharms LLC. Cromolyn Sodium.

As of Nov 14, 2026, NDA 18596 (Intal), held by King Pharms LLC, was first approved by FDA on May 28, 1982, with 22 approved supplements and 0 published complete response letters.

First approved: May 28, 1982
Review: Priority
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
May 28, 1982	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Intal10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Cromolyn Sodium	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Feb 11, 2004	Supplement 30Labeling · Standard review	Approved	Label Letter
Mar 6, 2002	Supplement 28Manufacturing · Priority review	Approved	None posted
Mar 6, 2002	Supplement 27Manufacturing · Priority review	Approved	None posted
May 27, 1997	Supplement 26Labeling · Standard review	Approved	None posted
Mar 18, 1996	Supplement 21Labeling · Standard review	Approved	None posted
Feb 26, 1996	Supplement 25Manufacturing · Priority review	Approved	None posted
Dec 18, 1995	Supplement 23Manufacturing · Priority review	Approved	None posted
Aug 9, 1993	Supplement 20Labeling · Standard review	Approved	None posted
Mar 18, 1993	Supplement 14Manufacturing · Priority review	Approved	None posted
Mar 18, 1993	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 15, 1988	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 28, 1986	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 29, 1986	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 5, 1986	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 5, 1986	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 19, 1985	Supplement 6Labeling	Approved	None posted
Nov 30, 1984	Supplement 7Manufacturing · Priority review	Approved	None posted
Sep 20, 1984	Supplement 4Labeling	Approved	None posted
Aug 31, 1984	Supplement 5Manufacturing · Priority review	Approved	None posted
Oct 11, 1983	Supplement 1Labeling	Approved	None posted
Dec 27, 1982	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 27, 1982	Supplement 2Labeling	Approved	None posted
May 28, 1982	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18596
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