Last Updated: November 8, 2026

Details for New Drug Application (NDA): 020021

NDA 020021 describes SUDAFED 24 HOUR, which is a drug marketed by Kenvue Brands and is included in one NDA. Additional details are available on the SUDAFED 24 HOUR profile page.

The generic ingredient in SUDAFED 24 HOUR is pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

Summary for 020021

Tradename:	SUDAFED 24 HOUR
Applicant:	Kenvue Brands
Ingredient:	pseudoephedrine hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 15, 1992	TE:		RLD:	Yes

Expired US Patents for NDA 020021

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	⤷ Start Trial	⤷ Start Trial
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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