Pseudoephedrine Hydrochloride And Chlorpheniramine Maleate

NDA 18843, held by Graham Dm. Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride.

As of Nov 13, 2026, NDA 18843 (Pseudoephedrine Hydrochloride And Chlorpheniramine Maleate), held by Graham Dm, was first approved by FDA on Mar 18, 1985, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 18, 1985
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 18, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pseudoephedrine Hydrochloride And Chlorpheniramine Maleate12MG;120MG · capsule, extended release;oral	Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 25, 1997	Supplement 5Labeling	Approved	None posted
Mar 18, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18843
Drugs@FDA: Overview at FDA
Company: Graham DM

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