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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020965
Company: DUSA

Products on NDA 020965

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVULAN	AMINOLEVULINIC ACID HYDROCHLORIDE	20%	SOLUTION;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020965

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20965lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20965ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-965_Levulan.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2022	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020965s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020965Orig1s017ltr.pdf
04/19/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020965Orig1s016ltr
03/06/2018	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020965Orig1s015ltr.pdf
01/07/2016	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/14/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/12/2010	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020965s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020965s007ltr.pdf
07/17/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020965s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020965s006ltr.pdf
07/11/2003	SUPPL-4	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965scm004ltr.pdf
06/27/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr003_levulan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr003ltr.pdf
03/26/2003	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr002_levulan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr002ltr.pdf
07/27/2001	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Labels for NDA 020965

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020965s017lbl.pdf
04/19/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s016lbl.pdf
03/06/2018	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s015lbl.pdf
03/12/2010	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020965s007lbl.pdf
07/17/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020965s006lbl.pdf
06/27/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr003_levulan_lbl.pdf
03/26/2003	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr002_levulan_lbl.pdf
12/03/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20965lbl.pdf

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