Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021119
Company: BAUSCH LOMB IRELAND
Company: BAUSCH LOMB IRELAND
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VISUDYNE | VERTEPORFIN | 15MG/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
04/12/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21119ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-119_Visudyne.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/12/2023 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021119Orig1s034ltr.pdf | |
07/09/2021 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021119s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021119Orig1s029ltr.pdf | |
05/11/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021119Orig1s027ltr.pdf | |
05/06/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/08/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/28/2012 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021119s022ltr.pdf | |
03/28/2007 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021119s021ltr.pdf | |
06/30/2008 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021119se8-013ltr.pdf | |
03/25/2005 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21119s012ltr.pdf | |
02/12/2004 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf |
02/12/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf |
11/25/2002 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119slr005ltr.pdf | |
05/29/2002 | SUPPL-4 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s004_Visudyne.cfm | |
04/30/2002 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s003_Visudyne.cfm | |
02/15/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/22/2001 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21119s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-119S001_Visudyne.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/12/2023 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf | |
02/12/2023 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf | |
07/09/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021119s029lbl.pdf | |
05/11/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf | |
06/28/2012 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf | |
06/30/2008 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf | |
03/28/2007 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf | |
03/25/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf | |
11/25/2002 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf | |
05/29/2002 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf |
04/30/2002 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf | |
08/22/2001 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf | |
04/12/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf |