Chlor-Trimeton

NDA 7638, held by Bayer Healthcare LLC. Chlorpheniramine Maleate.

As of Nov 13, 2026, NDA 7638 (Chlor-Trimeton), held by Bayer Healthcare LLC, was first approved by FDA on Aug 15, 1950, with 24 approved supplements and 0 published complete response letters.

First approved: Aug 15, 1950
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jan 30, 1986	Supplement 22Efficacy (new indication or use)	Approved	None posted
May 7, 1982	Supplement 13Efficacy (new indication or use)	Approved	None posted
Aug 15, 1950	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Chlor-Trimeton8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Chlorpheniramine Maleate	DiscontinuedReference drug
Chlor-Trimeton12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Chlorpheniramine Maleate	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 23, 2015	Supplement 38Manufacturing	Approved	Letter
Feb 4, 2008	Supplement 33Labeling · Standard review	Approved	Letter
Jan 19, 2006	Supplement 32Manufacturing · Standard review	Approved	Letter
Mar 6, 2002	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 26, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
May 19, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 17, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 20, 1997	Supplement 24Labeling · Standard review	Approved	None posted
Jul 8, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 30, 1986	Supplement 22Efficacy (new indication or use)	Approved	None posted
Jan 30, 1986	Supplement 18Labeling	Approved	None posted
Sep 18, 1984	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 18, 1983	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 4, 1983	Supplement 16Labeling	Approved	None posted
Aug 30, 1982	Supplement 15Manufacturing · Standard review	Approved	None posted
May 7, 1982	Supplement 13Efficacy (new indication or use)	Approved	None posted
Oct 30, 1981	Supplement 12Labeling	Approved	None posted
Jul 30, 1980	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 3, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 11, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 1, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 20, 1979	Supplement 7Labeling	Approved	None posted
Jan 5, 1979	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 18, 1978	Supplement 2Labeling	Approved	None posted
Aug 15, 1950	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 7638
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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