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 ALKEM LABS LTD
Abbreviated New Drug Application (ANDA): 090836
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription |
AB |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription |
AB |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 333MG BASE | CAPSULE;ORAL | Prescription |
None |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 750MG BASE | CAPSULE;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/20/2010 | 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 |
|---|---|---|---|---|---|
| 10/10/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2013 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CEPHALEXIN
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062713 | BELCHER PHARMS |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065215 | HIKMA |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065229 | LUPIN |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065248 | ORCHID HLTHCARE |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062702 | TEVA |
CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062713 | BELCHER PHARMS |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065215 | HIKMA |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065229 | LUPIN |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065248 | ORCHID HLTHCARE |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062702 | TEVA |
CAPSULE;ORAL; EQ 750MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 750MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
| KEFLEX | CEPHALEXIN | EQ 750MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050405 | PRAGMA |
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