اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CUTIVATE از شرکت FOUGERA PHARMS
New Drug Application (NDA): 019958
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| CUTIVATE | FLUTICASONE PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM;TOPICAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/18/1990 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 09/03/2010 | SUPPL-17 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019958s017ltr.pdf |
||
| 06/07/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/2002 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19958s13ltr.pdf |
||
| 01/21/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1999 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf |
||
| 08/08/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1997 | SUPPL-9 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 06/17/1999 | SUPPL-8 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19958s08ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19958S8_Cutivate.cfm |
||
| 06/07/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1991 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/03/2010 | SUPPL-17 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf | |
| 04/16/2002 | SUPPL-13 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf | |
| 06/17/1999 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf | |
| 06/17/1999 | SUPPL-8 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf |
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