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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 020135

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NDA 020135 describes MOTRIN, which is a drug marketed by Mcneil, Mcneil Consumer, Mcneil Ped, and Kenvue Brands, and is included in six NDAs. Additional details are available on the MOTRIN profile page.

The generic ingredient in MOTRIN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-one suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for 020135

Tradename:	MOTRIN
Applicant:	Mcneil Ped
Ingredient:	ibuprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 020135

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	50MG
Approval Date:	Nov 16, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	100MG
Approval Date:	Nov 16, 1994	TE:		RLD:	No

Expired US Patents for NDA 020135

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994	⤷ Get Started Free	⤷ Get Started Free
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	⤷ Get Started Free	⤷ Get Started Free
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994	⤷ Get Started Free	⤷ Get Started Free
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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