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 FACTA FARMA
Abbreviated New Drug Application (ANDA): 062206
Company: FACTA FARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CEFACLOR | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CEFACLOR | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CEFACLOR | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 04/23/1979 | 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 |
|---|---|---|---|---|---|
| 03/27/2000 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-50 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/20/1999 | SUPPL-49 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/30/1999 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 10/23/1997 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 11/13/1996 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1997 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/10/1996 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 06/23/1994 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1994 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/07/1993 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/31/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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