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): 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SOLARAZE	DICLOFENAC SODIUM	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TOPICAL	Discontinued	None	Yes	No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
11/21/2024	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021005s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021005Orig1s025ltr.pdf
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
11/21/2024	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021005s025lbl.pdf
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

Top