BIOFRONTERA Application 050769

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AKTIPAK	BENZOYL PEROXIDE; ERYTHROMYCIN	GEL;TOPICAL	5%;3%	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70363-007	Aktipak	erythromycin and benzoyl peroxide	Cutanea Life Sciences, Inc.	NDA	Current
70363-007	Aktipak	erythromycin and benzoyl peroxide	Cutanea Life Sciences, Inc.	NDA	Current