Last Updated: September 24, 2026

Details for New Drug Application (NDA): 011340

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NDA 011340 describes CERUMENEX, which is a drug marketed by Pharm Res Assoc and is included in one NDA. Additional details are available on the CERUMENEX profile page.

The generic ingredient in CERUMENEX is trolamine polypeptide oleate condensate. There is one drug master file entry for this compound. Additional details are available on the trolamine polypeptide oleate condensate profile page.

Summary for 011340

Tradename:	CERUMENEX
Applicant:	Pharm Res Assoc
Ingredient:	trolamine polypeptide oleate condensate
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OTIC			Strength	10%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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