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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 010841

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NDA 010841 describes PEGANONE, which is a drug marketed by Recordati Rare and is included in one NDA. Additional details are available on the PEGANONE profile page.

The generic ingredient in PEGANONE is ethotoin. There is one drug master file entry for this compound. Additional details are available on the ethotoin profile page.

Summary for 010841

Tradename:	PEGANONE
Applicant:	Recordati Rare
Ingredient:	ethotoin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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