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): 021535
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBEX | CLOBETASOL 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2003 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_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-Patient 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/2012/021535s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/30/2012 | SUPPL-3 |
Labeling-Patient 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/2012/021535s002lbl.pdf | |
| 07/24/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_clobex_lbl.pdf |
CLOBEX
LOTION;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% | LOTION;TOPICAL | Prescription | No | AB | 078223 | ACTAVIS MID ATLANTIC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 205249 | CADILA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 209147 | LUPIN LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 200302 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 208667 | TELIGENT |
| CLOBEX | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | Yes | AB | 021535 | GALDERMA LABS LP |
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