Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091390
Company: ZYDUS PHARMS
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

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 INC
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 INC
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 INC
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

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 INC
CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET;ORAL Prescription No AB 209119 ALEMBIC PHARMS LTD
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 091390 ZYDUS PHARMS

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