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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 017941

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NDA 017941 describes SUDAFED 12 HOUR, which is a drug marketed by Glaxosmithkline and Mcneil Cons and is included in two NDAs. Additional details are available on the SUDAFED 12 HOUR profile page.

The generic ingredient in SUDAFED 12 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

Summary for 017941

Tradename:	SUDAFED 12 HOUR
Applicant:	Glaxosmithkline
Ingredient:	pseudoephedrine hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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