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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204623
Company: HORIZON

Medication Guide

Summary Review

Products on NDA 204623

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENNSAID	DICLOFENAC SODIUM	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204623

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2014	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204623Orig1s011ltr.pdf
06/07/2021	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204623Orig1s010ltr.pdf
01/27/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204623s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204623Orig1s009ltr.pdf
10/31/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/11/2016	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204623Orig1s006ltr.pdf
05/09/2016	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204623Orig1s005ltr.pdf
05/06/2015	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/05/2014	SUPPL-3	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s003ltr.pdf
07/10/2014	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf
07/21/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204623

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204623s009lbl.pdf
06/07/2021	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623Orig1s010lbl.pdf
04/28/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623s011lbl.pdf
08/11/2016	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623Orig1s006lbl.pdf
05/09/2016	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf
05/09/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf
05/09/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf
11/05/2014	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s003lbl.pdf
07/10/2014	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf
01/16/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s000lbl.pdf

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