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
CORTISONE ACETATE از شرکت HIKMA INTL PHARMS
Abbreviated New Drug Application (ANDA): 080776
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTISONE ACETATE | CORTISONE ACETATE | 25MG | TABLET;ORAL | Prescription |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/1972 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/22/2002 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/2000 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/05/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
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