Details for New Drug Application (NDA): 209018

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NDA 209018 describes INGENOL MEBUTATE, which is a drug marketed by Padagis Israel and is included in two NDAs. Additional details are available on the INGENOL MEBUTATE profile page.

The generic ingredient in INGENOL MEBUTATE is ingenol mebutate. There are three drug master file entries for this compound. Additional details are available on the ingenol mebutate profile page.

Summary for 209018

Tradename:	INGENOL MEBUTATE
Applicant:	Padagis Israel
Ingredient:	ingenol mebutate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	0.015%
Approval Date:	Jan 7, 2019	TE:		RLD:	No

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