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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210302
Company: ALEMBIC 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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/04/2018 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
03/04/2021 SUPPL-5 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 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
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