Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021108
Company: VALEANT PHARMS NORTH
Company: VALEANT PHARMS NORTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RENOVA | TRETINOIN | 0.02% | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21108LTr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-108_Renova.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/25/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2014 | SUPPL-15 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021108Orig1s015ltr.pdf | |
| 01/08/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/14/2002 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21108slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/13/2014 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf |
| 07/14/2002 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf | |
| 08/31/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf |