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
CANDESARTAN CILEXETIL از شرکت MACLEODS PHARMS LTD
Abbreviated New Drug Application (ANDA): 203813
Company: MACLEODS PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/05/2016 | 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 |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/19/2017 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
CANDESARTAN CILEXETIL
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 210302 | ALEMBIC PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS PHARMS |
TABLET;ORAL; 8MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 210302 | ALEMBIC PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS PHARMS |
TABLET;ORAL; 16MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 210302 | ALEMBIC PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS PHARMS |
TABLET;ORAL; 32MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | Yes | AB | 020838 | ANI PHARMS |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 209119 | ALEMBIC PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 203813 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 078702 | MYLAN |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS PHARMS |
منبع : www.accessdata.fda.gov
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