Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021234
Company: IBSA
Company: IBSA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLECTOR | DICLOFENAC EPOLAMINE | 1.3% | SYSTEM;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 |
---|---|---|---|---|---|---|---|
01/31/2007 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021234s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021234s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021234s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021234Orig1s019ltr.pdf | |
03/01/2019 | SUPPL-17 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021234Orig1s016s017ltr.pdf | |
03/01/2019 | SUPPL-16 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021234Orig1s016s017ltr.pdf | |
08/30/2018 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021234Orig1s015ltr.pdf | |
05/09/2016 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021234Orig1s013,s014ltr.pdf | |
05/09/2016 | SUPPL-13 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021234Orig1s013,s014ltr.pdf | |
05/08/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/23/2011 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s009ltr.pdf | |
01/31/2011 | SUPPL-8 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s005,s008ltr.pdf |
09/03/2009 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf | |
09/03/2009 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021234s006ltr.pdf | |
01/31/2011 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s005,s008ltr.pdf | |
10/23/2008 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021234s004ltr.pdf |
06/04/2008 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021234s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021234s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021234s019lbl.pdf | |
03/01/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf | |
03/01/2019 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf | |
03/01/2019 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf | |
08/30/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf | |
05/09/2016 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf | |
05/09/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf | |
05/09/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf | |
05/09/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf | |
05/09/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf | |
05/09/2016 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf | |
02/23/2011 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s009lbl.pdf | |
01/31/2011 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s005lbl.pdf | |
09/03/2009 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf | |
09/03/2009 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf | |
06/04/2008 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021234s003lbl.pdf | |
01/31/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021234lbl.pdf |