Afrinol

NDA 18191, held by Schering Plough. Pseudoephedrine Sulfate.

As of Nov 13, 2026, NDA 18191 (Afrinol), held by Schering Plough, was first approved by FDA on Oct 30, 1980, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1980
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Oct 30, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Afrinol120MG · tablet, extended release;oral	Pseudoephedrine Sulfate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 11, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 24, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 1, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 17, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 18, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 17, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 7, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 15, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Jan 24, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 2, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 8, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 18, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 21, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 10, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 30, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18191
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