Nasalcrom

NDA 20463, held by Blacksmith Brands. Cromolyn Sodium.

As of Nov 13, 2026, NDA 20463 (Nasalcrom), held by Blacksmith Brands, was first approved by FDA on Jan 3, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 3, 1997
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 27, 2001	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Review
Jan 3, 1997	Original applicationTYPE 8 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nasalcrom5.2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Cromolyn Sodium	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 15, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Nov 27, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 27, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 27, 2001	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Review
Jun 12, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 4, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 3, 1997	Original applicationTYPE 8 · Standard review	Approved	None posted

Identifiers

Application: NDA 20463
Drugs@FDA: Overview at FDA
Company: Blacksmith Brands

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