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): 019957
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CUTIVATE | FLUTICASONE PROPIONATE | 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT;TOPICAL | Discontinued |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 |
---|---|---|---|---|---|---|---|
12/14/1990 | 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 |
---|---|---|---|---|---|
03/19/2021 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019957Orig1s013ltr.pdf |
||
02/18/2015 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf |
||
01/18/2002 | SUPPL-11 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf |
||
06/07/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/09/2001 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf |
||
06/30/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/09/2001 | SUPPL-7 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf |
||
11/12/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/07/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/07/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/17/1995 | 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 |
---|---|---|---|---|---|
03/19/2021 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf | |
02/18/2015 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf | |
01/18/2002 | SUPPL-11 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf | |
12/09/2001 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf | |
12/09/2001 | SUPPL-7 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf |
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