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): 012806
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORDRAN | FLURANDRENOLIDE | 0.05% | OINTMENT;TOPICAL | Prescription |
AT |
Yes | Yes |
| CORDRAN | FLURANDRENOLIDE | 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT;TOPICAL | Discontinued |
None |
Yes | No |
| CORDRAN SP | FLURANDRENOLIDE | 0.05% | CREAM;TOPICAL | Prescription |
AT |
Yes | Yes |
| CORDRAN SP | FLURANDRENOLIDE | 0.025% | CREAM;TOPICAL | Discontinued |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/18/1965 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 07/23/2013 | SUPPL-37 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf |
||
| 06/12/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012806Orig1s036ltr.pdf |
|
| 12/14/2012 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2008 | SUPPL-32 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12806scm028ltr.pdf |
|
| 11/06/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/1990 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/18/1987 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1987 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/08/1982 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/12/1980 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/24/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/11/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/23/2013 | SUPPL-37 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf |
CORDRAN
OINTMENT;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% | OINTMENT;TOPICAL | Prescription | Yes | AT | 012806 | ALMIRALL |
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AT | 207851 | TELIGENT |
CORDRAN SP
CREAM;TOPICAL; 0.05%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORDRAN SP | FLURANDRENOLIDE | 0.05% | CREAM;TOPICAL | Prescription | Yes | AT | 012806 | ALMIRALL |
| FLURANDRENOLIDE | FLURANDRENOLIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AT | 205342 | CINTEX SVCS |
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