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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050769
Company: BIOFRONTERA

Products on NDA 050769

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050769

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-769_Benamycin.cfm

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050769Orig1s017ltr.pdf
03/16/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/01/2002	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/28/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/23/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/03/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/17/2001	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/17/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/29/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/22/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

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