Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050769
Company: BIOFRONTERA

Products on NDA 50769

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKTIPAK	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 050769

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2016	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf