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
CEPHALEXIN از شرکت FACTA FARMA
Abbreviated New Drug Application (ANDA): 062117
Company: FACTA FARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | FOR SUSPENSION;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 03/27/1978 | 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-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/23/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1996 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/01/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/07/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/28/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
نظرات کاربران