Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091390
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
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 |
---|---|---|---|---|---|---|---|
08/23/2017 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091390Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/02/2024 | SUPPL-1 | Labeling-Package Insert |
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 |
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 LIFESCIENCES |
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 |
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 | 206233 | PRINSTON INC |
CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |
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 |
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 | 206233 | PRINSTON INC |
CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Prescription | No | AB | 091390 | ZYDUS LIFESCIENCES |
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 |