Sudafed 12 Hour

ANDA 73585, held by Mcneil Cons. Pseudoephedrine Hydrochloride.

As of Nov 15, 2026, ANDA 73585 (Sudafed 12 Hour), held by Mcneil Cons, was first approved by FDA on Oct 31, 1991, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1991
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 31, 1991	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sudafed 12 Hour120MG · tablet, extended release;oral	Pseudoephedrine Hydrochloride	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jan 15, 2019	Supplement 20Labeling · Standard review	Approved	None posted
Nov 14, 2018	Supplement 19Labeling · Standard review	Approved	None posted
Nov 6, 2001	Supplement 14Labeling	Approved	None posted
Sep 11, 2000	Supplement 13Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 12Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 11Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 10Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 9Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 8Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 7Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 6Manufacturing	Approved	None posted
Jul 12, 1999	Supplement 5Labeling	Approved	None posted
Jan 31, 1997	Supplement 4Labeling	Approved	None posted
Oct 31, 1991	Original application	Approved	Review

Identifiers

Application: ANDA 73585
Drugs@FDA: Overview at FDA
Company: Mcneil Cons

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