Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076300
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.005% | OINTMENT;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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76300ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076300_S000_FLUTICASONE PROPIONATETOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/08/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |