Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021152
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUTIVATE | FLUTICASONE PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/31/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021152ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021152s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2011 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021152s005ltr.pdf | |
| 01/16/2015 | SUPPL-4 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021152Orig1s004ltr.pdf | |
| 12/19/2014 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/03/2010 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021152s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/16/2015 | SUPPL-4 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf | |
| 05/12/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf | |
| 09/03/2010 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf |