Motrin

NDA 19842, held by Mcneil Consumer. Ibuprofen.

As of Nov 14, 2026, NDA 19842 (Motrin), held by Mcneil Consumer, was first approved by FDA on Sep 19, 1989, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 19, 1989
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

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


Mar 24, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 19, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Motrin100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suspension;oral	Ibuprofen	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Sep 10, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Jan 24, 2006	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 4, 2002	Supplement 13Labeling · Standard review	Approved	Review
May 14, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 18, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 22, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 7, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 23, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 23, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 23, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 24, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 13, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 23, 1993	Supplement 3Labeling · Standard review	Approved	None posted
Sep 19, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19842
Drugs@FDA: Overview at FDA
Company: Mcneil Consumer

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