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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204100
Company: MACLEODS PHARMS LTD

Products on ANDA 204100

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2015	ORIG-1	Approval				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-18	Labeling-Package Insert		Label is not available on this site.
06/23/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/23/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 204100

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 LIFESCIENCES

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 LIFESCIENCES

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 LIFESCIENCES

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