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Last Updated: April 9, 2025

Details for New Drug Application (NDA): 019672

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NDA 019672 describes EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE, which is a drug marketed by Alza and is included in one NDA. Additional details are available on the EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE profile page.

The generic ingredient in EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE is brompheniramine maleate; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the brompheniramine maleate; pseudoephedrine hydrochloride profile page.

Summary for 019672

Tradename:	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE
Applicant:	Alza
Ingredient:	brompheniramine maleate; pseudoephedrine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	16MG;240MG
Approval Date:	Mar 29, 1996	TE:		RLD:	No

Expired US Patents for NDA 019672

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Try for Free	⤷ Try for Free
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Try for Free	⤷ Try for Free
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Try for Free	⤷ Try for Free
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Showing 1 to 4 of 4 entries

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