Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021902
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VEREGEN SINECATECHINS 15% OINTMENT;TOPICAL Prescription None 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
10/31/2006 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021902Orig1s033Ltr.pdf
07/08/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/06/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/09/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/31/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/01/2013 SUPPL-26 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf
11/19/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf
09/18/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021902s017ltr.pdf
02/13/2008 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

06/27/2007 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/19/2007 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf
06/01/2007 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf
11/19/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf
09/18/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf
12/19/2007 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf
06/01/2007 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf
10/31/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English