Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021112
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRI-LUMA FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN 0.01%;4%;0.05% CREAM;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
01/18/2002 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-112_Tri-Luma.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/10/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/31/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021112Orig1s009ltr.pdf
10/18/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/12/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/16/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021112s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021112Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021112Orig1s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/31/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf
01/16/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021112s006lbl.pdf
01/18/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21112lbl.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