Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022315
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OZURDEX | DEXAMETHASONE | 0.7MG | 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 |
---|---|---|---|---|---|---|---|
06/17/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022315s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315_ozurdex_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/19/2022 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022315Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022315Orig1s016ltr.pdf | |
10/21/2020 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022315s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022315Orig1s013ltr.pdf | |
05/15/2018 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022315Orig1s012ltr.pdf | |
02/05/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s010ltr.pdf | |
06/28/2014 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022315Orig1s009.pdf | |
02/07/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s008ltr.pdf | |
09/07/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315Orig1s007ltr.pdf | |
02/24/2012 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315s005ltr.pdf | |
09/24/2010 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s003ltr.pdf | |
08/31/2010 | SUPPL-2 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/19/2022 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022315Orig1s016lbl.pdf | |
12/19/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022315Orig1s016lbl.pdf | |
10/21/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022315s013lbl.pdf | |
05/15/2018 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf | |
09/26/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf | |
06/28/2014 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf | |
02/07/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf | |
09/07/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf | |
02/24/2012 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf | |
09/24/2010 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf | |
06/17/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf |