Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021112
Company: GALDERMA LABS LP
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 |