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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207455
Company: PRINSTON INC
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
04/11/2018 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
05/13/2021 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

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
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
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
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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