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
CORTEF ACETATE از شرکت PHARMACIA AND UPJOHN
New Drug Application (NDA): 008917
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTEF ACETATE | HYDROCORTISONE ACETATE | 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT;TOPICAL | Discontinued |
None |
Yes | No |
| CORTEF ACETATE | HYDROCORTISONE ACETATE | 1% | OINTMENT;TOPICAL | Discontinued |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/1953 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 07/05/1990 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1987 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1987 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/14/1982 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/19/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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