Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090704
Company: MYLAN
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
12/04/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090704Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/19/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/19/2015 SUPPL-2 Labeling-Package Insert

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 INC
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 PHARMS

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 INC
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 PHARMS

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 INC
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 PHARMS

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