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
CEFACLOR از شرکت CEPH INTL
Abbreviated New Drug Application (ANDA): 062205
Company: CEPH INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Discontinued |
None |
No | No |
| CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/1979 | 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 |
|---|---|---|---|---|---|
| 05/01/2000 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-49 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-48 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/30/1999 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 03/03/1999 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1997 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/01/1997 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 06/10/1996 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1994 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/24/1994 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/03/1992 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
نظرات کاربران