Chlor-Trimeton

NDA 6921, held by Schering. Chlorpheniramine Maleate.

As of Nov 14, 2026, NDA 6921 (Chlor-Trimeton), held by Schering, was first approved by FDA on Jul 13, 1949, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1949
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 13, 1949	Original application	Approved	None posted

Products

2 strengths and forms


Chlor-Trimeton4MG · tablet;oral	Chlorpheniramine Maleate	Discontinued
Chlor-Trimeton2MG/5ML · syrup;oral	Chlorpheniramine Maleate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 6, 1979	Supplement 7Labeling	Approved	None posted
Sep 13, 1978	Supplement 5Labeling	Approved	None posted
Jun 26, 1978	Supplement 4Labeling	Approved	None posted
Jul 13, 1949	Original application	Approved	None posted

Identifiers

Application: NDA 6921
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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