Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076633
Company: ENCUBE
Company: ENCUBE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | CREAM;TOPICAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/14/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76633ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076633_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2012 | SUPPL-16 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/24/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |