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 TEVA
Abbreviated New Drug Application (ANDA): 063024
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 01/12/1989 | 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 |
|---|---|---|---|---|---|
| 02/22/2011 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf |
||
| 09/27/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/08/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/19/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/22/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/18/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/12/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/18/2012 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf |
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