Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018702
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACLOVATE | ALCLOMETASONE DIPROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/14/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/05/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf | |
| 07/26/2002 | SUPPL-8 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf | |
| 04/02/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf | |
| 06/22/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/07/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/05/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf | |
| 04/02/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf | |
| 07/26/2002 | SUPPL-8 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf |