Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021737
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RETISERT | FLUOCINOLONE ACETONIDE | 0.59MG | IMPLANT;INTRAVITREAL | 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 |
---|---|---|---|---|---|---|---|
04/08/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021737ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021737s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/30/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/2011 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021737s019ltr.pdf | |
11/30/2010 | SUPPL-18 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021737s018ltr.pdf |
08/05/2008 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021737s010ltr.pdf |
10/30/2007 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021737s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/02/2011 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf | |
10/30/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf | |
04/08/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf |