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
CLOBEX از شرکت GALDERMA LABS LP
New Drug Application (NDA): 021835
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 10/27/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/21/2018 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021835s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021835Orig1s015Ltr.pdf |
||
| 04/15/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/2012 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s007ltr.pdf |
||
| 09/07/2012 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s006ltr.pdf |
||
| 01/12/2011 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf |
||
| 01/12/2011 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf |
||
| 02/13/2007 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2018 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021835s015lbl.pdf | |
| 09/07/2012 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf | |
| 08/17/2012 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf | |
| 01/12/2011 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf | |
| 01/12/2011 | SUPPL-2 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf | |
| 01/12/2011 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf | |
| 10/27/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf |
CLOBEX
SPRAY;TOPICAL; 0.05%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 211191 | ALEOR DERMACEUTICALS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 209004 | GLENMARK PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 208125 | LUPIN LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 090898 | PADAGIS US |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 208842 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 206378 | ZYDUS PHARMS |
| CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | Yes | AT | 021835 | GALDERMA LABS LP |
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