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): 021152
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUTIVATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/31/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021152ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2011 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021152s005ltr.pdf |
||
| 01/16/2015 | SUPPL-4 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021152Orig1s004ltr.pdf |
||
| 12/19/2014 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2010 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021152s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/16/2015 | SUPPL-4 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf | |
| 05/12/2011 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf | |
| 09/03/2010 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf |
CUTIVATE
LOTION;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CUTIVATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | Yes | AB | 021152 | FOUGERA PHARMS |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 090759 | GLENMARK GENERICS |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 091553 | PERRIGO ISRAEL |
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