Motrin

NDA 20135, held by Mcneil Ped. Ibuprofen.

As of Nov 13, 2026, NDA 20135 (Motrin), held by Mcneil Ped, was first approved by FDA on Nov 16, 1994, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 16, 1994
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 24, 1995	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 16, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Motrin50MG · tablet, chewable;oral	Ibuprofen	Discontinued
Motrin100MG · tablet, chewable;oral	Ibuprofen	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 5, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 4, 2002	Supplement 5Labeling · Standard review	Approved	Review Letter
May 14, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 2, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 24, 1995	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 16, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20135
Drugs@FDA: Overview at FDA
Company: McNeil Pediatrics

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