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
CORTONE از شرکت MERCK
New Drug Application (NDA): 007750
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTONE | CORTISONE ACETATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/04/1950 | 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 |
|---|---|---|---|---|---|
| 03/01/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/30/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/02/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/01/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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