An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021234
Company: IBSA

Medication Guide

Products on NDA 021234

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021234

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-Container/Carton Labels, Labeling-Package Insert	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-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
05/08/2013	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

Labels for NDA 021234

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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.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-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-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
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

Top