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
CEFUROXIME AXETIL از شرکت ALKEM LABS LTD
Abbreviated New Drug Application (ANDA): 065496
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/07/2010 | 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 |
|---|---|---|---|---|---|
| 12/19/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
CEFUROXIME AXETIL
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065496 | ALKEM LABS LTD |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065069 | APOTEX |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065308 | AUROBINDO PHARMA LTD |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065135 | LUPIN |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065359 | ORCHID HLTHCARE |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065166 | WOCKHARDT |
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065496 | ALKEM LABS LTD |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065069 | APOTEX |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065308 | AUROBINDO PHARMA LTD |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065135 | LUPIN |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065359 | ORCHID HLTHCARE |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065166 | WOCKHARDT |
منبع : www.accessdata.fda.gov
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