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): 062703
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 02/13/1987 | 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 |
|---|---|---|---|---|---|
| 08/21/2012 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/22/2011 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 09/27/2007 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 02/09/2007 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 01/13/2004 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/13/2004 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/01/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/18/2000 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/27/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
CEPHALEXIN
FOR SUSPENSION;ORAL; EQ 125MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210221 | ALKEM LABS LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065234 | LUPIN |
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065326 | ORCHID HLTHCARE |
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062703 | TEVA |
| CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065336 | YUNG SHIN PHARM |
FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210221 | ALKEM LABS LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065234 | LUPIN |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065326 | ORCHID HLTHCARE |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062703 | TEVA |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065336 | YUNG SHIN PHARM |
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