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 AND HYDROCHLOROTHIAZIDE از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 090704
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/04/2012 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090704Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/13/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 16MG;12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 021093 | ANI PHARMS |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 202965 | DR REDDYS LABS LTD |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 204100 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 090704 | MYLAN |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 207455 | PRINSTON INC |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 203466 | ZYDUS PHARMS |
TABLET;ORAL; 32MG;12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 021093 | ANI PHARMS |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 202965 | DR REDDYS LABS LTD |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 204100 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 090704 | MYLAN |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 207455 | PRINSTON INC |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 203466 | ZYDUS PHARMS |
TABLET;ORAL; 32MG;25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATACAND HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 021093 | ANI PHARMS |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 202965 | DR REDDYS LABS LTD |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 204100 | MACLEODS PHARMS LTD |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 090704 | MYLAN |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 207455 | PRINSTON INC |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET;ORAL | Prescription | No | AB | 203466 | ZYDUS PHARMS |
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