Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202965
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
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 |
---|---|---|---|---|---|---|---|
06/03/2013 | ORIG-1 | Approval |
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 LIFESCIENCES |
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 LIFESCIENCES |
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 LIFESCIENCES |