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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021005
Company: FOUGERA PHARMS

Medication Guide

Products on NDA 021005

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLARAZE	DICLOFENAC SODIUM	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021005

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21005_Solaraze.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2022	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021005Orig1s024ltr.pdf
04/05/2022	SUPPL-23	Labeling-Package Insert	Label (PDF) Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s023lbl.pdf#page=21
04/28/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021005s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021005Orig1s022ltr.pdf
05/16/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/09/2016	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021005Orig1s016ltr.pdf
03/30/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/08/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021005s013ltr.pdf
06/01/2007	SUPPL-10	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021005s010ltr.pdf
07/23/2004	SUPPL-9	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005s009ltr.pdf
03/18/2004	SUPPL-7	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005scs007ltr.pdf
04/29/2003	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21005slr006_solaraze_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21005slr006ltr.pdf
12/13/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/20/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/02/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/2001	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021005

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s024lbl.pdf
04/05/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005Orig1s023lbl.pdf
04/05/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s023lbl.pdf#page=21
04/28/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021005s022lbl.pdf
05/09/2016	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf
05/09/2016	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf
12/08/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021005s013lbl.pdf
04/29/2003	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21005slr006_solaraze_lbl.pdf
10/16/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21005lbl.pdf

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