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
CORDRAN از شرکت ALMIRALL
New Drug Application (NDA): 013790
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORDRAN | FLURANDRENOLIDE | 0.05% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 03/19/1963 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 07/27/2011 | SUPPL-21 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/013790s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/013790s021ltr.pdf |
||
| 10/31/2003 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13790scm018ltr.pdf |
|
| 09/27/2000 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/06/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/17/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/27/2011 | SUPPL-21 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/013790s021lbl.pdf |
CORDRAN
LOTION;TOPICAL; 0.05%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORDRAN | FLURANDRENOLIDE | 0.05% | LOTION;TOPICAL | Prescription | Yes | AT | 013790 | ALMIRALL |
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | LOTION;TOPICAL | Prescription | No | AT | 205343 | CINTEX SVCS |
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | LOTION;TOPICAL | Prescription | No | AT | 207133 | PADAGIS ISRAEL |
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