Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020965
Company: DUSA
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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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