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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 073585

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NDA 073585 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 073585

Tradename:	SUDAFED 12 HOUR
Applicant:	Mcneil Cons
Ingredient:	pseudoephedrine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Oct 31, 1991	TE:		RLD:	No

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