Drixoral, Disophrol

NDA 13483, held by Schering Plough. Dexbrompheniramine Maleate; Pseudoephedrine Sulfate.

As of Nov 14, 2026, NDA 13483 (Drixoral, Disophrol), held by Schering Plough, was first approved by FDA on Oct 18, 1963, with 27 approved supplements and 0 published complete response letters.

First approved: Oct 18, 1963
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Oct 18, 1963	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Drixoral6MG;120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Dexbrompheniramine Maleate; Pseudoephedrine Sulfate	DiscontinuedReference drug
Disophrol6MG;120MG · tablet, extended release;oral	Dexbrompheniramine Maleate; Pseudoephedrine Sulfate	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Mar 10, 2005	Supplement 42Manufacturing · Standard review	Approved	Letter
Jul 11, 2001	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 29, 2001	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 6, 2001	Supplement 37Manufacturing · Standard review	Approved	None posted
Jan 24, 2001	Supplement 35Manufacturing · Standard review	Approved	None posted
Oct 17, 2000	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 18, 2000	Supplement 34Manufacturing · Standard review	Approved	None posted
Nov 18, 1998	Supplement 31Manufacturing · Standard review	Approved	None posted
Oct 6, 1998	Supplement 33Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 24, 1989	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 8, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 22, 1986	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 20, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 21, 1984	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 18, 1984	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 13, 1982	Supplement 17REMS · Standard review	Approved	None posted
Sep 13, 1982	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 1, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 11, 1981	Supplement 15Labeling	Approved	None posted
Jul 21, 1980	Supplement 14Labeling	Approved	None posted
Jun 13, 1980	Supplement 13Manufacturing · Standard review	Approved	None posted
May 7, 1980	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 2, 1978	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 14, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
May 15, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 30, 1976	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 18, 1963	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 13483
Drugs@FDA: Overview at FDA
Company: Schering-Plough

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