Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020965
Company: DUSA
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 |
---|---|---|---|---|---|
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. |
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 |