Opticrom

NDA 18155, held by Allergan. Cromolyn Sodium.

As of Nov 13, 2026, NDA 18155 (Opticrom), held by Allergan, was first approved by FDA on Oct 3, 1984, with 23 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1984
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jun 11, 1993	Supplement 18Efficacy (new indication or use)	Approved	None posted
Oct 3, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Opticrom4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Cromolyn Sodium	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 19, 2003	Supplement 28Labeling · Standard review	Approved	None posted
Apr 12, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 24, 2001	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 13, 2001	Supplement 22Labeling · Standard review	Approved	None posted
Oct 2, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 3, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 11, 1993	Supplement 18Efficacy (new indication or use)	Approved	None posted
Oct 13, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 22, 1992	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 9, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 4, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 23, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 23, 1987	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 12, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 2, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 24, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 20, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 23, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 24, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 28, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 16, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 3, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18155
Drugs@FDA: Overview at FDA
Company: Allergan

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