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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 089139

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NDA 089139 describes RESPORAL, which is a drug marketed by Pioneer Pharms and is included in one NDA. Additional details are available on the RESPORAL profile page.

The generic ingredient in RESPORAL is dexbrompheniramine maleate; pseudoephedrine sulfate. There are seven drug master file entries for this compound. Additional details are available on the dexbrompheniramine maleate; pseudoephedrine sulfate profile page.

Summary for 089139

Tradename:	RESPORAL
Applicant:	Pioneer Pharms
Ingredient:	dexbrompheniramine maleate; pseudoephedrine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG;120MG
Approval Date:	Jun 16, 1988	TE:		RLD:	No

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