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
New Drug Application (NDA): 021644
Company: GALDERMA LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;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 |
---|---|---|---|---|---|---|---|
02/05/2004 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/30/2012 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf |
||
08/17/2012 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021644Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/30/2012 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf | |
08/17/2012 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf | |
02/05/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf |
CLOBEX
SHAMPOO;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 078854 | ACTAVIS MID ATLANTIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 209871 | AKORN |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 213290 | ALEOR DERMACEUTICALS |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 214895 | AMNEAL |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 090974 | PERRIGO ISRAEL |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 214867 | TARO PHARMS |
CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | Yes | AB | 021644 | GALDERMA LABS |
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