Details for New Drug Application (NDA): 020021

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NDA 020021 describes SUDAFED 24 HOUR, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the SUDAFED 24 HOUR profile page.

The generic ingredient in SUDAFED 24 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 020021

Tradename:	SUDAFED 24 HOUR
Applicant:	J And J Consumer Inc
Ingredient:	pseudoephedrine hydrochloride
Patents:	0

Pharmacology for NDA: 020021

Mechanism of Action	Adrenergic alpha-Agonists

Suppliers and Packaging for NDA: 020021

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021	NDA	Johnson & Johnson Consumer Inc.	50580-240	50580-240-01	1 BLISTER PACK in 1 CARTON (50580-240-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	240MG
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
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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