Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021005
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLARAZE DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription AB 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
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
05/16/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/09/2016 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf
05/09/2016 SUPPL-16 Labeling-Medication Guide 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

SOLARAZE

GEL;TOPICAL; 3%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 206493 ACTAVIS MID ATLANTIC
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 208301 GLENMARK PHARMS LTD
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 210893 PERRIGO UK FINCO
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 206298 TARO
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 200936 TOLMAR
SOLARAZE DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription Yes AB 021005 FOUGERA PHARMS

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