Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209119
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
06/20/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/08/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
CANDESARTAN CILEXETIL
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 |
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 | 206233 | PRINSTON INC |
CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |