Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021234
Company: INST BIOCHEM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLECTOR DICLOFENAC EPOLAMINE 1.3% PATCH;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
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-Medication Guide, 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
05/08/2013 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
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-Medication Guide 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
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

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