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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 050769

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NDA 050769 describes AKTIPAK, which is a drug marketed by Biofrontera and is included in one NDA. Additional details are available on the AKTIPAK profile page.

The generic ingredient in AKTIPAK is benzoyl peroxide; erythromycin. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.

Summary for 050769

Tradename:	AKTIPAK
Applicant:	Biofrontera
Ingredient:	benzoyl peroxide; erythromycin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	5%;3%
Approval Date:	Nov 27, 2000	TE:		RLD:	Yes

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