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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 088318

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NDA 088318 describes TRIPROLIDINE AND PSEUDOEPHEDRINE, which is a drug marketed by Watson Labs, West Ward, Kv Pharm, and Cenci, and is included in five NDAs. Additional details are available on the TRIPROLIDINE AND PSEUDOEPHEDRINE profile page.

The generic ingredient in TRIPROLIDINE AND PSEUDOEPHEDRINE is codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.

Summary for 088318

Tradename:	TRIPROLIDINE AND PSEUDOEPHEDRINE
Applicant:	Watson Labs
Ingredient:	pseudoephedrine hydrochloride; triprolidine hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG;2.5MG
Approval Date:	Jan 13, 1984	TE:		RLD:	No

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