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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208081
Company: BIOFRONTERA

Products on NDA 208081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMELUZ	AMINOLEVULINIC ACID HYDROCHLORIDE	10%	GEL;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208081s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208081Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208081Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2024	SUPPL-26	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208081Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208081Orig1s026ltr.pdf
05/25/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208081s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208081Orig1s011ltr.pdf
09/06/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208081Orig1s002ltr.pdf

Labels for NDA 208081

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2024	SUPPL-26	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208081Orig1s026lbl.pdf
05/25/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208081s011lbl.pdf
09/06/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf
05/10/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208081s000lbl.pdf

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