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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 086008

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NDA 086008 describes ALPHADERM, which is a drug marketed by Bioglan and is included in one NDA. Additional details are available on the ALPHADERM profile page.

The generic ingredient in ALPHADERM is hydrocortisone; urea. There are sixty-seven drug master file entries for this compound. Additional details are available on the hydrocortisone; urea profile page.

Summary for 086008

Tradename:	ALPHADERM
Applicant:	Bioglan
Ingredient:	hydrocortisone; urea
Patents:	0

Profile for product number 001

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

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